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NCT01243463 · ClinicalTrials.gov registry record

Bariatric Surgery and Obstructive Sleep Apnea

A clinical trial, sponsored by Summa Health System.

Completed
Registry status
20
Enrollment target

NCT01243463: Completed study, sponsored by Summa Health System.

NCT01243463 is a clinical trial that has completed, run by Summa Health System. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01243463 has completed, sponsored by Summa Health System.

COMPLETED
Registry status
20 participants
Enrollment target

Study Summary

More often than not, obesity occurs in tandem with Obstructive Sleep Apnea (OSA), and each disease effectively perpetuates severity of the other. Surgical weight loss (i.e. bariatric surgery), and nocturnal, positive airway pressure therapy (PAP) are used to treat the two conditions separately, and these treatment modalities both present a unique set of challenges in terms of patient-adherence. Furthermore, the combined effects of these therapies on body weight and OSA severity are unclear, and require longitudinal investigation. The purpose of the research proposed herein is twofold: A) To prospectively demonstrate the specific physiologic/psychological improvements in OSA risk factors and disease severity that occur in a subset of bariatric surgery patients with OSA, who are being effectively treated with PAP and furthermore; B) To elucidate differences in postoperative outcomes (weight-loss, dyslipidemia, OSA severity, comorbidity resolution) between patients who are compliant or non-compliant with prescribed PAP therapy. The investigators anticipate that results will be used to develop and streamline approaches to improve pulmonary/sleep-related outcomes in bariatric surgery patients. Furthermore, this line of research has many implications for strategies to strengthen the coordination of care between bariatric surgery, pulmonology, and other clinical sub-specialties that are integral to the postoperative health of these patients.

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2010-02
Summa Health System

13 total trials

What the finished NCT01243463 record still lists

NCT01243463 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01243463 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01243463 about?

NCT01243463 is a clinical study titled "Bariatric Surgery and Obstructive Sleep Apnea". More often than not, obesity occurs in tandem with Obstructive Sleep Apnea (OSA), and each disease effectively perpetuates severity of the other. Surgical weight loss (i.e. bariatric surgery), and nocturnal, positive airway pressure therapy (PAP) are used to treat the two conditions separately, and ...

What is the current status of trial NCT01243463?

This trial is currently completed. The enrollment target is 20 participants. The study started on 2010-02.

Who is sponsoring clinical trial NCT01243463?

This trial is sponsored by Summa Health System, which has 13 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01243463, the US trial registry maintained by the National Library of Medicine. NCT01243463 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.