Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Diabetes Mellitus

Syndrome

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Polycystic Ovary Syndrome

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Estrogens

Leuprolide

Progesterone

Progestins

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive estrogen plus placebo for another 6 weeks.

Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive progesterone plus placebo for another 6 weeks.

Randomized to receive CPAP (continuous positive airway pressure) treatment for 6 weeks.

A single intramuscular dose of depot lupron (11.25 mg). Six weeks after injection, subjects will receive daily oral doses of estrogen (2mg) plus placebo for six weeks.

Depot Lupron followed by estrogen plus placebo

A single intramuscular dose of depot lupron (11.25 mg). Six weeks after injection, subjects will receive daily oral doses of progesterone (200mg) plus placebo for six weeks.

Depot Lupron followed by progesterone plus placebo.

CPAP (continuous positive airway pressure) treatment at home for six weeks.

CPAP

David A Ehrmann, MD

The purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in women with polycystic ovary syndrome (PCOS).

The prevalence of obesity and chronic sleep loss are at record levels among Americans and evidence continues to emerge to support a causal link between the two conditions. Metabolic abnormalities related to sleep disruption are particularly evident in individuals with obstructive sleep apnea (OSA), a disorder traditionally associated with male gender. While more prevalent in men, OSA is underrecognized in women in part because its clinical and polysomnographic features differ from those of men. Women with polycystic ovary syndrome (PCOS) are particularly susceptible to OSA with at least a 5-fold higher risk for its development compared to obese women without PCOS. This study will enroll obese women with PCOS, with and without OSA. Those with OSA will be randomized to receive CPAP or to receive depot leuprolide to suppress ovarian steroid output over 12 weeks, reassessed at 6 weeks, and then randomized (double-blind, placebo controlled) to 6 weeks of either micronized estrogen + placebo or micronized progestin + placebo. The independent effects of androgen, estrogen, and progesterone on OSA and metabolic function will be assessed. In addition, primary human adipocytes will be prepared from fat biopsies obtained from subjects. Insulin sensitivity will be determined by phospho-specific immunoblotting in conjunction with glucose uptake and anti-lipolysis assays. In parallel, adipocytes from these subjects will be cultured for 1-5 days prior to metabolic assays to ascertain if removal of from circulating factors will improve insulin signaling, or if insulin resistance persists in vitro. Finally, there will be an interface with the Metabolomics Laboratory at Duke University (C. Newgard, Lab Director), and metabolomics assessment will be done on blood and urine samples.

Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea

PCOS, Sleep Apnea and Metabolic Risk in Women

Duke University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

University of Chicago

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Mouth Diseases

Oropharyngeal Neoplasms

Laryngeal Diseases

Hypopharyngeal Neoplasms

Otorhinolaryngologic Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Subjects ≥ 22 yrs requiring transoral procedures

Michael D Tricoli, BS, MBA

The objectives of this study are to evaluate the performance of the Medrobotics Flex® Robotic System to visualize and access specific anatomical locations along with evaluation of the safety of the device.

A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures

A Multicenter OUS Post-Market Clinical Follow-Up of the Medrobotics Flex® Robotic System Used for Accessing and Visualizing the Oropharynx, Hypopharynx, and Larynx During Transoral Procedures

Ability to access and visualize all the following anatomical locations in the oropharynx, hypopharynx and larynx via transoral only approach. Palatine tonsils, base of tongue, epiglottis, posterior pharyngeal wall, false vocal cords.

Medrobotics Corporation

Rare Diseases

Oculocerebral Syndrome With Hypopigmentation

Women with confirmed diagnosis of PCOS, based on the Rotterdam Criteria. To assess risk of OSA: the risk of OSA will be assessed using the Berlin questionnaire and the Epworth Sleepiness Scale (ESS). Women with at high risk of OSA will have home-based sleep studies performed.

The risk of OSA will be assessed using the Berlin questionnaire and the Epworth Sleepiness Scale (ESS). Women with at high risk of OSA will have home-based sleep studies performed. Study participants will be divided based on the results of the Berlin and ESS questionnaires and sleep studies into two groups: 1) PCOS low risk OSA: women with normal ESS and normal Berlin questionnaire (no sleep studies performed), or women with normal sleep studies; and 2) PCOS OSA: women with OSA proven by sleep studies.

To assess risk of OSA

Martin O Weickert, MD, FRCP

Women with PCOS and OSA, compared to women with PCOS only, have more severe clinical and biochemical features of PCOS and impaired QoL. This is an observational cross-sectional study in a secondary care PCOS clinic in the WISDEM Centre, University Hospital Coventry.

The primary aim of this study is to examine the relationship between OSA and impaired QoL in women with PCOS. Study secondary outcomes are to examine the relationship between OSA and the clinical and biochemical features in women with PCOS.

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS is associated with multiple co-morbidities including obesity, insulin resistance, subfertility, impaired quality of life (QoL) and increased risk of type 2 diabetes. Obstructive sleep apnoea (OSA) is a common medical condition that is often undiagnosed, particularly in women. Obesity is a common risk factor for OSA and PCOS and OSA is associated with comorbidities similar to those observed in patients with PCOS such as insulin resistance, increased risk of type 2 diabetes, and impaired QoL. Hence it is not surprising that OSA and PCOS might co-exist.

However, the impact of OSA in women with PCOS remains unclear and understudied. It is plausible that OSA may contribute to the subfertility and impaired QoL observed in women with PCOS by increasing insulin resistance, activation of the sympathetic nervous system, disturbing the hypothalamic/pituitary/ovarian axis, and contributing to excessive daytime sleepiness and reduced mood.

38 women with PCOS will be recruited from the PCOS clinic, weight management clinic, reproductive endocrinology clinic and through posters displayed at University Hospital Coventry and an e-poster displayed at the hospital intranet. Women with increased risk of OSA, based on the Berlin questionnaire and the Epworth Sleepiness Scale (ESS), will have home-based sleep studies performed. They will also be referred to the Respiratory Physician, as part of routine NHS care.

Study participants will be divided based on the results of the Berlin and ESS questionnaires and sleep studies into two groups: 1) PCOS low risk OSA: women with normal ESS and normal Berlin questionnaire (no sleep studies performed), or women with normal sleep studies; and 2) PCOS OSA: women with OSA proven by sleep studies.

Clinical and biochemical features including reproductive history, depression and anxiety \[using the Hospital Anxiety and Depression questionnaire (HAD)\], and QoL \[using the PCOS health-related quality of life questionnaire (PCOSQ) and the World Health Organisation QoL-BREF will be compared between the two groups.

The Impact of Obstructive Sleep Apnoea in Women With Polycystic Ovary Syndrome.

The Impact of Obstructive Sleep Apnoea in Women With Polycystic Ovary Syndrome: A Cross-sectional Study

Quality of life will be measured using the World Health Organisation QoL-BREF (WHOQOL-BREF) questionnaire.

Participants will be asked to recall how many periods they had in the last 4 months.

Participants will be asked to complete HAD questionnaire.

Fasting plasma glucose and insulin will be measured to calculate HOMA-IR

Quality of life will be measured using the PCOS health-related quality of life questionnaire (PCOSQ).

Hirsutism will be measured using the modified Ferriman-Gallwey score.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea	NCT00696111	Polycystic Ovar... Obstructive Sle...	Depot Lupron fo... Depot Lupron fo... CPAP	18 Years - 40 Years	University of Chicago
Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea	NCT00696111	Polycystic Ovar... Obstructive Sle...	Depot Lupron fo... Depot Lupron fo... CPAP	18 Years - 40 Years	University of Chicago
A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures	NCT02262247	OSA Oral Disease Oropharyngeal N... Hypopharyngeal ...		22 Years -	Medrobotics Corporation
The Impact of Obstructive Sleep Apnoea in Women With Polycystic Ovary Syndrome.	NCT03065322	Polycystic Ovar... Obstructive Sle...	To assess risk ...	18 Years -	University Hospitals Coventry and Warwickshire NHS Trust

Spots Global Cancer Trial Database for osa

Every month we try and update this database with for osa cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for osa

Every month we try and update this database with for osa cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for osa cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.