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NCT01840618 · ClinicalTrials.gov registry record
Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents
A clinical trial, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- 50
- Enrollment target
NCT01840618: Completed study, sponsored by Albert Einstein College of Medicine.
NCT01840618 is a clinical trial that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01840618 has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
Polycystic ovary syndrome (PCOS) is one of the most common disease caused by hormonal imbalance and is also associated with overweight and obesity. It affects 5-10% of adolescent girls and women capable of having children. Polycystic ovary syndrome is associated with missed menstrual periods, hormonal imbalance, being overweight, and with a form of diabetes. Girls with polycystic ovary syndrome may have a breathing problem known as "sleep apnea." Sleep apnea may cause a person to stop breathing for short periods of time while sleeping. People with polycystic ovary syndrome are thirty times more likely to develop sleep apnea than those who do not have PCOS. If sleep apnea is not treated, it may lead to daytime sleepiness, poor school performance, high blood pressure, heart disease and diabetes. The purpose of this study is to understand how insulin function is affected in presence of sleep apnea in girls with polycystic ovary syndrome between 13-21 years of age as compared to girls with PCOS without sleep apnea. Insulin is one of the hormones made in your body to convert food into energy. In people with increase weight body cannot use insulin properly. The investigators also want to see if insulin action is also affected by sleep apnea.
Primary Outcome
Obese adolescents with PCOS will be assessed for presence or absence of Obstructive Sleep Apnea (OSA) at baseline. Obese PCOS with OSA will be compared with obese PCOS with out OSA for difference in Glucose Infusion Rate (GIR) as a measure of insulin resistance and for Reactive Hyperemia Peripheral Arterial Tonometry (RHPAT) score
Interventions
- DEVICE Nasal Continuous positive airway pressure (CPAP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-02 |
| Est. Completion | 2015-06 |
What the finished NCT01840618 record still lists
NCT01840618 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Nasal Continuous positive airway pressure (CPAP) is the first listed.
NCT01840618 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01840618 about?
NCT01840618 is a clinical study titled "Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents". Polycystic ovary syndrome (PCOS) is one of the most common disease caused by hormonal imbalance and is also associated with overweight and obesity. It affects 5-10% of adolescent girls and women capable of having children. Polycystic ovary syndrome is associated with missed menstrual periods, hormon...
What is the current status of trial NCT01840618?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2012-02. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01840618?
The interventions under investigation include: Nasal Continuous positive airway pressure (CPAP) (DEVICE).
Who is sponsoring clinical trial NCT01840618?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
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