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NCT01944020 · ClinicalTrials.gov registry record · NA

Effects of CPAP on Diet, Physical Activity, and Cardiovascular Risk

A NA study, sponsored by Columbia University.

Completed
Registry status
NA
Development phase
29
Enrollment target

NCT01944020: Completed NA study, sponsored by Columbia University.

NCT01944020 is a NA study that has completed, run by Columbia University. The registered enrollment target is 29 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01944020, a NA study, has completed, sponsored by Columbia University.

COMPLETED
Registry status
NA
Development phase
29 participants
Enrollment target

Study Summary

Obstructive sleep apnea (OSA) is characterized by recurrent episodes of partial or complete loss of airflow during sleep, due to narrowing or closure of the upper airway. The resulting hypoxia has many cardiometabolic consequences, and leads to a disruption of sleep quality including reductions in the expression of rapid eye movement (REM) sleep and slow wave sleep (SWS). Patients also frequently experience excessive daytime sleepiness (EDS), which, when present with OSA, defines the clinical entity OSA syndrome (OSAS). Obesity is the leading risk factor for the development of OSA. Interestingly, it has been suggested that the disorder itself may contribute to further weight gain, presenting a vicious cycle wherein OSA and obesity perpetuate each other. OSAS may promote weight gain by placing patients in a state of positive energy balance characterized by low levels of physical activity and disrupted patterns of appetite-regulating hormones. Continuous positive airway pressure (CPAP), the gold-standard treatment of OSAS, may improve energy balance in these patients, although this has not yet been adequately studied. The current proposal will investigate the effects of 2 months of CPAP on energy balance and cardiovascular risk in obese patients with OSA. Patients will be instructed to use CPAP at home each night throughout the 2-month treatment phases. At baseline and at the conclusion of the 2-month treatment phase, the investigators will measure levels of free-living physical activity, sleepiness, sleep quality, body composition, cardiovascular risk factors, appetite-regulating hormones, hunger, and ad libitum food intake. There will also be a control group with OSA individuals studied at baseline and again after 2 months with no CPAP use. It is hypothesized that CPAP compared to no treatment treatment will result in improvements in energy balance, including increased physical activity, reductions in abnormally high levels of circulating leptin levels, and reductio

Primary Outcome

Fat mass (% of total body mass) measured via BODPOD at baseline preceding treatment phase, and at the end of treatment phase.

Interventions

  • DEVICE CPAP

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2015-05
Est. Completion 2018-09
Phase NA
Columbia University

958 total trials

What the finished NCT01944020 record still lists

NCT01944020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which CPAP is the first listed.

NCT01944020 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01944020 about?

NCT01944020 is a clinical study titled "Effects of CPAP on Diet, Physical Activity, and Cardiovascular Risk". Obstructive sleep apnea (OSA) is characterized by recurrent episodes of partial or complete loss of airflow during sleep, due to narrowing or closure of the upper airway. The resulting hypoxia has many cardiometabolic consequences, and leads to a disruption of sleep quality including reductions in t...

What is the current status of trial NCT01944020?

This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2015-05. Estimated completion is 2018-09.

What interventions are being tested in trial NCT01944020?

The interventions under investigation include: CPAP (DEVICE).

Who is sponsoring clinical trial NCT01944020?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01944020's enrollment target sits among peer trials

29 1702nd of 2000 higher than 297 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01944020, the US trial registry maintained by the National Library of Medicine. NCT01944020 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.