Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Nervous System Diseases

Urinary Incontinence

Ganglion Cysts

Enuresis

Synovial Cyst

Nocturnal Enuresis

Cysts

Chronobiology Disorders

Mucinoses

Connective Tissue Diseases

Urination Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Behavioral Symptoms

Elimination Disorders

Mental Disorders

Psychotic Disorders

Lower Urinary Tract Symptoms

Urological Manifestations

Yasar ISSI

The precise role of the intrinsic circadian regulatory mechanism behind the pathogenesis of enuresis is not fully understood, but in theory, circadian rhythm irregularity may be the primary pathogenic mechanism not only for urinary outflow mechanisms but also for nocturnal bladder function. The proximity between SCN centers that control AVP release, sleep/arousal, voiding, and baroreregulation may provide the basis for circadian rhythm disturbance in one or more of these biological functions. Ganglion cells containing melanopsin pigment in the retina transmit the information they receive from the outside world about the light-dark state to the SCN via the retinohypothalamic pathway. Peripapillary retinal nerve fiber layer (RNFL) thickness, optic nerve head and macula are examined most frequently for the diagnosis of glaucoma and the detection of progression with optical coherence tomography (OCT). If differences in ganglion cell thickness can be detected using OCT in these children, a new avenue in Enuresis Nocturna may be opened.

Ganglion Cell Thickness in Enuresis Nocturna

Is Ganglion Cell Thickness the Main Problem in Enuresis Nocturna?

Normal values in RNFL measurements on OCT 75 (lowest)-107.2 (highest)

Izmir Bakircay University

Asistant Professor

Breast Neoplasms

Syndrome

Inflammation

Depression

Depressive Disorder

Cognitive Dysfunction

Fatigue

Stress, Psychological

Quality of Life

Ali Amidi, PhD

Lisa M Wu, PhD

Emerging evidence indicates that circadian rhythms may be disrupted following cancer and its treatment, and that circadian rhythm disruption may be an underlying pathophysiological mechanism of cancer- and cancer treatment-related symptoms (CRS) such as fatigue, sleep disturbance, cognitive impairment, and depressed mood. Given the detrimental effect of CRS on cancer survivors' quality of life, and a pressing demand for effective interventions to treat CRS, there is a need for a comprehensive examination of circadian disruption related to cancer and its treatment, and its association with CRS. The study will prospectively examine circadian rhythms and a CRS composite score in recently diagnosed breast cancer patients from prior to surgery or chemotherapy to 12 months later. A matched healthy control group will serve as a comparison.

Saliva samples for melatonin. Blood samples for inflammatory cytokines.

The Role of Circadian Rhythms in Cancer-Related Symptoms

The Role of Circadian Rhythms in Cancer-Related Symptoms: A Prospective Controlled Chrono-Bio-Behavioral Observation Study

A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes

Rest/wake activity recorded with wrist actigraphy

Distal skin temperature recorded with wrist actigraphy

Objective sleep recorded with wrist actigraphy

Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples.

Functional Assessment of Cancer Therapy - Cognitive function issues (FACT-Cog)

Center for Epidemiologic Studies Depression Scale (CESD)

University of Aarhus

Danish Cancer Society

Aarhus University Hospital

Assistant Professor

Anxiety Disorders

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Melatonin

12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III.

Wrist-Actigraph to be worn on the non-dominant arm on day 0-3-17 of the study.

Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA

Polysomnography on day 0-3-17 of the study. This is a portable polysomnograph with 16 digital channels for recording of electroencephalogram (EEG), electrooculograph (EOG) and electromyograph (EMG).

Polysomnograph - Embla A10 (Medcare, Reykjavik, Iceland)

Holter monitoring on day 0-3-17 of the study. Measurements are done by superficial skin-electrodes placed after standardised rules from the producer of the device.

Holter monitor - Medilog AR12 (Oxford Instruments, Oxford, England)

Urine sampling for measurement of the primary metabolite of melatonin - 6-sulphatoxymelatonin (aMT6s) will be done on day 0-3-17 of the study. The analysis will be done by a radioimmunoassay.

Urine 6-sulphatoxymelatonin (aMT6s)

Karolinska Sleepiness Scale to measure sleepiness will be filled out twice a day every day of the entire study period of 17 days.

Karolinska Sleepiness Scale

Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain will be filled out twice a day everyday of the study period of 17 days.

Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain

Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day.

Sleep-diary

Melissa V Hansen, MD

The purpose of this study is to investigate circadian disturbances after breast cancer surgery by means of monitoring sleep and heart-rate variability, by measuring a metabolite of melatonin in urine and by questionnaires and a sleep-diary.

An increasing number of studies have shown that circadian variation in the excretion of hormones, the sleep-wake cycle, the core body temperature, the tone of the autonomic nervous system and the activity rhythm are important both in health and disease processes. More attention is being paid towards the circadian variation in endogenous rhythms in relation to surgery and whether this can affect postoperative recovery, morbidity and mortality.

Studies have been done on circadian disturbances after major and minor surgery but never in relation to breast cancer surgery.

This study will investigate circadian disturbances in this specific group of patients by using Actigraphy, Polysomnography (PSG), Holter-monitoring (HRV), the primary metabolite of melatonin in urine 6-sulfatoxymelatonin (aMT6s), questionnaires and a sleep-diary.

Circadian Disturbances After Breast Cancer Surgery

Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings).

Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings)

Fatigue, generel well-being, subjective sleep and pain scores on a Visual Analog Scale - questionnaires filled out daily. Sleepiness measured by Karolinska Sleepiness Scale. A sleep-diary recording sleep quantity of day and night sleep.

Excretion of aMT6s in urine. Urine will be collected from 23-07, quantified and 2 samples will be taken to measure aMT6s.

Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings). A wrist actigraph wil be worn from 1 day preoperatively and taken off on the 14th postoperative day.

Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters.

Melissa Voigt Hansen

M.D. ph.D student

Single arm study receiving a multi-modal intervention

A psychoeducational and evidence-based skills and strategies course for insomnia delivered online over four lessons through ThisWayUp. This will be completed during an 8-week feasibility trial.

Cognitive behavioural therapy for Insomnia (CBT-I)

Daily bright light therapy for 30 minutes on waking delivered using the Lumie-L light box during an 8-week feasibility trial.

Bright Light Therapy

An individualised activity plan is created at baseline and adjusted weekly aiming to increased daytime physical activity and reduce sedentary behaviours. The activity plan takes into consideration personal interests, perceived barriers to activity and develops an activity plan using Specific Measureable Achievable Realistic and Timely (SMART) goals. This will take place during an 8-week feasibility trial.

Individualised activity plan

Two clinical reviews will take place during an 8-week feasibility trial and consider uncontrolled symptoms, medication and blood test abnormalities which may impact on rest and physical activity levels

Clincial review

Craig Gouldthorpe

Circadian rest-activity rhythm disorders are common in patients with cancer, particularly in advanced disease. A recent international e-Delphi study has outlined recommendations for the assessment and reporting of the disorder and subsequently an observation study is underway assessing a cohort of patients with advanced cancer. Affected patients are eligible to enter a feasibility study assessing a non-pharmacological multi-modal intervention.

A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)

The RALI Study: a Multimodal Non-pharmacological (Clinical Review, Physical Activity, Bright Light Therapy and Cognitive Behavioural Therapy for Insomnia) Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Patients With Advanced Cancer

Patient completed questionnaire of the acceptability and usability of interventions and research assessments

Patient completed weekly diary of adherence to the interventions and weekly monitoring by the researcher

Number of subjects develop adverse events during the trial in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)

Number of participants completing the midpoint and end of study assessments

Number of participants recruited to the feasibility study over a 1 year period

Memorial Symptom Assessment Score Short Form (MSAS-SF). The scale assesses the presence and level of distress (Not at all, A little bit, Somewhat, Quite a bit, Very much) associated with 32 physical and psychological symptoms. Higher scores suggest increased symptomatology and increased distress

European Organisation for Research and Treatment of Cancer QLQ-C30. Participants rate 28 symptom and quality of life measures on a scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Higher scores suggest a worser outcome. Participants also rate their overall health and quality of life on a scale 1-7 (1 = very poor, 7 = excellent).

Epworth Sleepiness Scale. Participants rate the likelihood of falling asleep in 8 scenarios. Higher scores suggest increased daytime sleepiness

Brief Pittsburgh Sleep Quality Index (bPSQI). Participants complete 6 questions with higher scores suggesting poorer sleep quality.

Physical activity will be captured over a continuous 72-hour period using wrist and thigh accelerometry. Accelerometry devices collect activity counts during 1 minute periods (epochs).

A novel diary will be completed. Daytime physical activity will be assessed (level of tiredness, level of exertion, time spent during different activity intensities). Additional medication, smoking, caffeine and alcohol use will be documented. Nighttime sleep will also be assessed (time in bed, time to lights off, time to fall asleep, waking time, out of bed time, sleep quality).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ganglion Cell Thickness in Enuresis Nocturna	NCT05126732	Enuresis, Noctu... Ganglion Circadian Rhyth...		5 Years - 18 Years	Izmir Bakircay University
The Role of Circadian Rhythms in Cancer-Related Symptoms	NCT04401189	Breast Cancer Fatigue Cognitive Impai... Sleep Depression Quality of Life Stress, Psychol... Inflammation Circadian Rhyth... Cancer-Related ...		18 Years -	Aarhus University Hospital
Circadian Disturbances After Breast Cancer Surgery	NCT01171508	Circadian Rhyth... Anxiety Breast Cancer	Wrist-Actigraph... Polysomnograph ... Holter monitor ... Urine 6-sulphat... Karolinska Slee... Visual Analog S... Sleep-diary	30 Years - 70 Years	Herlev Hospital
A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)	NCT06329479	Circadian Rhyth... Cancer	Cognitive behav... Bright Light Th... Individualised ... Clincial review	18 Years -	University of Dublin, Trinity College
The Role of Circadian Rhythms in Cancer-Related Symptoms	NCT04401189	Breast Cancer Fatigue Cognitive Impai... Sleep Depression Quality of Life Stress, Psychol... Inflammation Circadian Rhyth... Cancer-Related ...		18 Years -	Aarhus University Hospital

Spots Global Cancer Trial Database for circadian rhythm disorders