The research intervention is, for all twenty patients, to wear a smart t-shirt connected to a smart phone throughout the day (preferably 8 hours pr day) for 2 weeks.

The patients will be asked to wear a smart shirt. The shirt is designed with multiple sensors and electrodes fully embedded which engender 6 different measurement flows continuously. The smart t-shirt system is washable, and patients can wash and dry this t-shirt anytime, thus the shirt can be worn repeatedly.

Wearable sensor

Cecilie Holländer-Mieritz, MD

The study will assess the feasibility of using the ChronolifeTM smart t-shirt for home monitoring of vital parameters in cancer patients during their treatment course. This study will bring new insights to how wearables and biometric data can be used as a part of symptom recognition in cancer patients during treatment course in the quest of increasing patients' quality of life.

Collecting biometric sensor data by wearables is an example of real-time patient-generated health data that can provide vital and detailed objective information about patients. This may have the potential to improve quality of oncological treatment and increase patients' quality of life.

Studies have shown that there may be a dissimilar perception on symptoms and side effects between patients and health care professionals. Wearables may help identifying symptoms earlier.

A new design of a wearable is a smart t-shirt. A smart t-shirt has sensors embedded in the fabric which generate measurement flows. This new tool provide more precise information without recall and reporting bias which may have the potential to lead to a better and more accurate cancer treatment.

Feasibility of Monitoring Cancer Patients With a Smart T-shirt: Protocol for the OncoSmartShirt Study

Changes in heart rate (beat per minute) will be presented descriptively.

Changes in skin temperature (°C) will be presented descriptively.

Changes in physical activity (steps) will be presented descriptively.

Changes in respirations frequency (respiration per minute) will be presented descriptively.

Changes in thoracic impedance (kOhm) will be presented descriptively.

To assess the feasibility of using the ChronolifeTM smart t-shirt based on the completion rate which is defined as the number of included patients using the smart t-shirt at least 12 hours pr. day during the three weeks study period.

To assess technical feasibility in a Danish healthcare system including data acquisition rate and data completeness.

Rigshospitalet, Denmark

Professor, MD

Neoplasms

Nervous System Diseases

Immune System Diseases

All Conditions

Musculoskeletal Diseases

Symptoms and General Pathology

Rare Diseases

Myasthenia Gravis

Muscle Weakness

Paresis

Asthenia

Muscular Diseases

Neuromuscular Manifestations

Neurologic Manifestations

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neurodegenerative Diseases

Neuromuscular Junction Diseases

Neuromuscular Diseases

All Drugs and Chemicals

Antibodies

Immunoglobulins

Existing patients at MassGeneral Hospital's MG clinic, ages 18-80, with autoimmune, AChR or MuSK antibody positive generalized myasthenia gravis.

Participants will wear a pendant sensor for 7 days and then participate in an on-site examination with using a tablet designed to evaluate weakness in MG.

Carina C Stafstrom, BS

Carina Stafstrom, BS

Amanda C Guidon, MD, MPH

The goal of this observational study is to evaluate the feasibility of using wearable sensor and digital technologies to measure motor and speech function in adults with autoimmune Myasthenia Gravis (MG).

The main question\[s\] it aims to answer are:

* To measure the correlation of sensor-based measures of motor function with existing outcome measures including the MG-ADL, MGQOL15r, QMG, MGComposite, and Neuro-QOL Fatigue scales.
* To develop and validate tablet-based digital assessments of speech and facial expression and to compare with existing outcome measures.

Participants will wear a pendant sensor for 7 days and then participate in tablet-based and in-person myasthenia-specific physical examinations. This will be performed in concert with routine care in the Massachusetts General Hospital MG clinic.

Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disease characterized by fluctuating muscle weakness and symptoms that interfere with activities of daily living and negatively impacts quality of life. MG symptoms are currently assessed in person through a careful history and physical exam by a neuromuscular disease expert. Such in-clinic assessments are time-consuming, subjective, only provide a snapshot of a patient's disease and do not adequately reflect the spectrum of fluctuating weakness and symptoms. In 2019, NIH funded a rare disease clinical research consortium called MGNet. The consortium is focused on improved characterization of clinical phenotypes, discovery of biomarkers, and advancing clinical trial readiness for MG, which would enhance the development of more effective and personalized treatments. In this Fast Track SBIR project, BioSensics will collaborate with Massachusetts General Hospital - one of the key Consortium sites for MGNet - to develop and validate a wearable sensor solution (MGWear) for continuous remote monitoring of motor symptoms and function in MG patients and also a secure mobile application (MG app) for automatic assessment of speech and facial characteristics. The mobile application will also enable the transfer of data from the wearable device to BioSensics HIPAA-compliant backend cloud called BioDigit Cloud.

The objective of the study is to evaluate the feasibility of using wearable sensor and digital technologies to measure motor and speech function as well as developing metrics to measure ocular and facial expression to monitor disease activity and fluctuating muscle weakness in people with Myasthenia Gravis (MG).To achieve this objective, the investigators will conduct an observational study is to investigate the correlation between outcomes as measured by the PAMSys sensor and digital health technologies with the total score and sub-scores of MG specific outcome measures.

A key application and market for the proposed solution technology is pharmaceutical clinical trials. Wearable sensors and digital technologies like the technology proposed here could allow drug developers to test and iterate faster, providing a valuable new method for evaluating efficacy. Clinically, the proposed solution could be used to predict an individual's response to immunosuppressive drugs and to improve medication titration. Such solutions can enable detecting subtle changes in movement-based and digital biomarkers and provide insight into the phase of clinical disease onset. Additionally, the growing use of telemedicine to expand access and potentially reduce costs of high-quality care will require remote assessment strategies. 20% of states in the US (10 out of 50 states) have no specialized care for MG. Travel time, distance and cost may limit patients' access to expert care, even in states with identified MG specialists. The proposed remote monitoring technologies have potential to lessen barriers to quality care access for MG patients.

Physical Activity Monitoring in Myasthenia Gravis

Wearable Sensor and Digital Technologies for Quantitative Assessment and Remote Monitoring of Symptoms in Myasthenia Gravis

To measure the correlation of sensor-based measures of motor function to the MG-ADL, QMG, MGC, and Neuro-QOL Fatigue.

To develop and validate digital assessment of speech and facial expression compared to rating of MG-ADL, QMG, MGC, and Neuro-QOL Fatigue.

BioSensics

Massachusetts General Hospital

Assistant Professor of Neurology/Harvard Medical School

Digestive System Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Participants will be trained to initiate swallowing during expiration.

Participants will practice swallowing, but will not learn the key therapeutic element (i.e., initiating swallowing during expiration).

Participants will complete 6 respiratory-swallow phase training sessions that will last approximately one hour.

Respiratory-Swallow Phase Training

Participants will complete 6 "swallow practice" sessions that will last approximately one hour.

Swallow Practice

Bonnie Martin-Harris, PhD

Head and neck cancers have escalated to epidemic levels in the United States, and survivors are suffering from life-long, devastating swallowing disorders with limited therapeutic options. This clinical trial investigates a novel swallowing treatment that trains initiation of swallowing during the expiratory phase of respiration to improve swallowing safety and efficiency.

Head and neck cancers (HNC) have increased to epidemic levels in the United States. Despite good response to cancer treatment, survivors are suffering life-long toxicities that result in swallowing problems (dysphagia). Treatment options for dysphagia after HNC are extremely limited, focus on swallowing movements alone, and do not consider the importance of respiratory-swallow phase patterning. Prior evidence has demonstrated that when aberrant respiratory-swallow phase patterning is present (initiation of swallowing during inspiration) in patients with HNC, there is a higher occurrence of swallowing impairments, increased residue, and airway invasion. Further, it has been well established that the expiratory limb of the respiratory cycle provides a biomechanically advantageous set point in which to initiate safe and efficient swallowing. This randomized, controlled, Phase II clinical trial examines if respiratory-swallow phase training improves airway protection and swallowing efficiency in HNC survivors who are three or more months post-completion of first-line cancer treatment. The primary goal (Aim 1) is to determine if respiratory-swallow phase training results in increased frequency (%) of swallows initiated during expiration and improved swallowing safety. The secondary goal (Aim 2) is to examine the impact of respiratory-swallow phase training on the frequency of swallows initiated during expiration in wakeful, naturalistic swallowing environments, including eating and drinking. The investigators will recruit 88 HNC survivors with dysphagia, impaired respiratory-swallow phase patterning, and airway compromise. The investigators will deliver therapy remotely using a telehealth platform and an innovative wearable sensor that provides real-time visual feedback of respiratory-swallow movements. Endpoints will be measured from synchronized videofluoroscopic and respiratory-swallow sensor recordings at baseline, within 1-week post-treatment, and 1-month and 3-months post-treatment.

Participants and outcome assessors will be naive to experimental condition.

Training Swallowing Initiation During Expiration

Training Swallowing Initiation During Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer

Evaluates the impact of dysphagia on the quality of life of patients with head and neck cancer

Determines percent (frequency) of the target (expiratory phase) for each swallow.

Measures presence, depth and reaction to penetration and aspiration.

Quantifies pharyngeal space residue obtained in the lateral view during Modified Barium Swallow Study (MBSS)

Measures physiologic swallowing impairment from observations of MBSS recordings

Northwestern Memorial Hospital

Northwestern University

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Prostatic Neoplasms

Breast Neoplasms

Fatigue

Hematologic Neoplasms

Hematologic Diseases

Central Nervous System Stimulants

Cardiotonic Agents

Methamphetamine

Sympathomimetics

Dopamine

Dopamine Agents

Neurotransmitter Agents

Adrenergic Agents

Dopamine Uptake Inhibitors

Light intervention delivered through SYNC app + blue-light blocking glasses.

Placebo light intervention delivered through SYNC app + clear glasses.

Patient is given a wearable device to wear for 12 weeks.

Wearable Sensor

Patient is given blue-blocking glasses to wear at instructed times.

Blue-blocking glasses

Patient is given glasses that block no visible light.

Clear glasses

Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.

Full SYNC app

Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.

"Dummy" SYNC app

Sung Choi, MD

Fatigue is a major problem for cancer patients, and one that can persist long after treatment ends. Recent work has demonstrated that light therapy may mitigate or reduce fatigue levels in both cancer patients and cancer survivors. This protocol seeks to assess how lighting interventions distributed through a mobile app affect fatigue, sleep, and quality of life across three populations of cancer patients: breast cancer and prostate cancer, and patients who have undergone autologous hematopoietic stem cell transplant (HSCT). Participants will be randomized 1:1 to either the interventional SYNC app or to a control app.

Blocked randomization will be used to limit bias and achieve an equal distribution of participants to the intervention and control arms of the study (69 control, 69 intervention; with 23 from each cancer population in each arm). This approach will recruit participants in small blocks to ensure that half of the participants within each block will be allocated to the treatment and the other half to the control.

Lighting Intervention for Cancer-related Fatigue

A Randomized Trial Of The SYNC APP

The change from baseline in PROMIS 4-item Fatigue scores will enable the investigators to quantify the effects of the light interventions delivered by SYNC on patient fatigue. The final fatigue score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10 points. The average change in PROMIS fatigue T scores will be calculated for each arm. A negative change (lower scores) represents improvement in symptoms; a positive change (higher scores) represents worsening of symptoms. The study will have power of 0.80, assuming a two-sided Type I error rate of 0.05, to detect an effect size of half the standard deviation between the intervention and control arms if the accrual goal is reached.

8-item PROMIS sleep disturbance questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

7-item PROMIS anxiety questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

8-item PROMIS depression questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

8-item PROMIS physical function questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

PROMIS Global-10 is a 10-question survey used as an overall evaluation of one's physical and mental health. Raw scores are converted to T-scores. Higher scores reflect better functioning.

Arcascope, Inc

National Cancer Institute (NCI)

University of Michigan Rogel Cancer Center

Patients with head and neck cancer require chemo and radiation therapy (Cohort A):

A wearable sensor device will be issued at the time of trial enrollment. Patients will be instructed to wear the device on their wrist for 23 hours per day, 7 days per week, from the time of their radiation simulation through one week following the end of radiation treatment

Patients with head and neck cancer require primary surgery alone (Cohort B-SA)

A wearable sensor device will be issued at the time of trial enrollment. Patients will be instructed to wear the device on their wrist for 23 hours per day, 7 days per week, from one week before surgery through 1 month following surgery

Patients with head and neck cancer require primary surgery and postoperative radiotherapy (Cohort B-RT)

A wearable sensor device will be issued at the time of trial enrollment. Patients will be instructed to wear the device on their wrist for 23 hours per day, 7 days per week, from one week before surgery to one week following the end of radiation treatment .

A commercially-available wearable fitness sensor

wearable sensor

David Sher, MD

The investigator will seek to determine the feasibility of wearable biometric sensors to acquire high resolution biometric data, including heart rate and activity level (i.e. steps) for patients undergoing radiation therapy and surgery, with or without postoperative radiotherapy.

Active cancer treatment such as surgery, chemotherapy or radiotherapy can cause side effects or toxicities, which, if untreated, can lead to poorer quality of life, decreased patient well-being, and worse clinical outcomes. Routine monitoring of patients while under active treatment can entail the routine practice of clinic visits at regular intervals with the acquisition of vital signs, routine laboratory testing, patient-reported outcome surveys, and face-to-face interaction with their physician.

In recent years, the availability of commercially-available wearable fitness sensors has allowed end-users to monitor their fitness progress and activity levels. These devices depend on small sensors that can collect minute-to-minute data on heart rate and activity level that may be transmitted to a smartphone or computer. Through this system, users can easily track and monitor their fitness progress.

In this trial, the investigator will seek to determine the feasibility of wearable biometric sensors to acquire high resolution biometric data, including heart rate and activity level (i.e. steps) for patients undergoing radiation therapy and surgery, with or without postoperative radiotherapy. The investigator believe that changes in heart rate may predict for increasing pain, dehydration, and stress in general. Moreover, changes in daily step count are a surrogate for performance status on treatment, and the investigator will perform a series of preliminary analyses to assess whether there is validity to this hypothesis. The investigator hope to use biometric monitoring to identify patients at risk for adverse outcomes, with the ultimate goal of intervening before these outcomes occur.

Wearable Sensor for Biometrics During Locoregional Therapy for Head and Neck Cancer

Feasibility Study of a Wearable Sensor for Acquisition of Biometric Data in Head and Neck Cancer Patients During Locoregional Therapy

To determine the feasibility of using a commercially-available wearable sensor to obtain biometric data for patients undergoing head and neck locoregional therapy throughout the duration of radiation treatment (cohorts A, B-RT) and throughout post-surgical recovery with or without adjuvant radiotherapy (cohort B)

Percentage of successful data acquisition events as well as a retention rate of all enrolled participants.

Data will be collected using the Fitbit device and aggregated using the Fitabase platform throughout the duration of radiation treatment (cohorts A, B-RT) and throughout post-surgical recovery with or without adjuvant radiotherapy (cohort B).

To analyze associations between biometric parameters and complications and interventions by the volume of intravenous fluids required for patients undergoing radiation treatment (cohorts A, B-RT) and surgical recovery +/-adjuvant radiotherapy (cohort B).

To analyze associations between biometric parameters and complications and interventions days of inpatient hospitalization required for patients undergoing radiation treatment (cohorts A, B-RT) and surgical recovery +/-adjuvant radiotherapy (cohort B).

To analyze associations between biometric parameters and complications and interventions by changes in pain level of patients undergoing radiation treatment (cohorts A, B-RT) and surgical recovery +/-adjuvant radiotherapy (cohort B).

Pain assessments are based on self-report. Pain scale from 0 no pain, 1-3 minor pain, 4-6 moderate pain to 7-10 severe pain.

To analyze associations between biometric parameters and complications and interventions number of emergency department visits required for patients undergoing radiation treatment (cohorts A, B-RT) and surgical recovery +/-adjuvant radiotherapy (cohort B).

To analyze associations between biometric parameters and complications and interventions utilization of pain medication required for patients undergoing radiation treatment (cohorts A, B-RT) and surgical recovery +/-adjuvant radiotherapy (cohort B).

Medication Quantification Scale (MQS) Version III will be used to determine drug detriment weight and dosage level.

To analyze associations between biometric parameters and patient-reported outcomes in regards to physical and mental well-being using the Functional Assessment of Cancer Therapy - General (FACT-G) Health Survey at each weekly scheduled visit to monitor for acute changes in their condition.

To analyze associations between biometric parameters and patient-reported outcomes in regards to sleep quality using the Pittsburgh Sleep Quality Index (PSQI)

The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.

University of Texas Southwestern Medical Center

The research intervention is continuously monitoring of heart rate and physical activity (minimum 12h/day) with a smartwatch which is connected to a smartphone.

The patients will be asked to wear an Apple Watch during their treatment course. The watch will pasively collect sensor data (heart rate and physical activity)

The aim of the study is to determine the adherence to using an Apple Watch during curative intended radiotherapy for head and neck cancer. Secondly it will bring new insights to the patient's activity levels and how heart rate varies during treatment course.

Patients with head and neck cancer (HNC) experience severe side effects during radiotherapy (RT). Ongoing technological advances in wearable biometric sensors allow for real-time collection of objective data e.g. physical activity and heart rate, which in the future might help to detect and act against side effects before they become severe. A smartwatch such as the Apple Watch allows for objective data monitoring outside hospital with minimal effort for the patient. To find out if such tools can be implemented in the oncological setting feasibility studies are needed.

The aim of the study is to determine the adherence to using an Apple Watch during curative intended radiotherapy for head and neck cancer. Secondly it will bring new insights to the patient's activity levels and how heart rate varies during treatment course.

The study will assess the feasibility of using the Apple Watch for home monitoring of patients with HNC. It will bring new insights to the patient's activity levels and how heart rate varies during treatment course. This is important knowledge before further investigating how biometric data can be used as part of symptom monitoring.

Feasibility of Monitoring Patients During Radiotherapy Using Biometric Sensor Data: the OncoWatch Study 1.0

Description of change in hear rate during radiotherapy

Description of change insteps per day during radiotherapy

To determine the feasibility of using an Apple Watch to obtain biometric data for patients undergoing head and neck locoregional therapy throughout the duration of radiotherapy

Percentage of successful data acquisition events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of Monitoring Cancer Patients With a Smart T-shirt: Protocol for the OncoSmartShirt Study	NCT05235594	Cancer	Wearable sensor	18 Years -	Rigshospitalet, Denmark
Physical Activity Monitoring in Myasthenia Gravis	NCT06277830	Myasthenia Grav...	Wearable sensor	18 Years - 80 Years	Massachusetts General Hospital
Training Swallowing Initiation During Expiration	NCT05278039	Head and Neck C... Dysphagia Oropharyngeal D... Oropharynx Squa...	Respiratory-Swa... Swallow Practic...	18 Years -	Northwestern University
Lighting Intervention for Cancer-related Fatigue	NCT04827446	Breast Cancer Prostate Cancer Hematologic Mal... Survivorship Fatigue	Wearable Sensor Blue-blocking g... Clear glasses Full SYNC app "Dummy" SYNC ap...	18 Years -	University of Michigan Rogel Cancer Center
Lighting Intervention for Cancer-related Fatigue	NCT04827446	Breast Cancer Prostate Cancer Hematologic Mal... Survivorship Fatigue	Wearable Sensor Blue-blocking g... Clear glasses Full SYNC app "Dummy" SYNC ap...	18 Years -	University of Michigan Rogel Cancer Center
Wearable Sensor for Biometrics During Locoregional Therapy for Head and Neck Cancer	NCT03574870	Cancer of Head ...	wearable sensor	18 Years - 120 Years	University of Texas Southwestern Medical Center
Feasibility of Monitoring Patients During Radiotherapy Using Biometric Sensor Data: the OncoWatch Study 1.0	NCT04613232	Head and Neck C...	Wearable sensor	18 Years -	Rigshospitalet, Denmark
Physical Activity Monitoring in Myasthenia Gravis	NCT06277830	Myasthenia Grav...	Wearable sensor	18 Years - 80 Years	Massachusetts General Hospital
Training Swallowing Initiation During Expiration	NCT05278039	Head and Neck C... Dysphagia Oropharyngeal D... Oropharynx Squa...	Respiratory-Swa... Swallow Practic...	18 Years -	Northwestern University
Lighting Intervention for Cancer-related Fatigue	NCT04827446	Breast Cancer Prostate Cancer Hematologic Mal... Survivorship Fatigue	Wearable Sensor Blue-blocking g... Clear glasses Full SYNC app "Dummy" SYNC ap...	18 Years -	University of Michigan Rogel Cancer Center
Training Swallowing Initiation During Expiration	NCT05278039	Head and Neck C... Dysphagia Oropharyngeal D... Oropharynx Squa...	Respiratory-Swa... Swallow Practic...	18 Years -	Northwestern University
Wearable Sensor for Biometrics During Locoregional Therapy for Head and Neck Cancer	NCT03574870	Cancer of Head ...	wearable sensor	18 Years - 120 Years	University of Texas Southwestern Medical Center

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