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CompletedNCT01243463BAROSAUpdated Jul 21, 2011

Bariatric Surgery and Obstructive Sleep Apnea

An observational study in Obstructive Sleep Apnea and Bariatric Surgery, sponsored by Summa Health System. Completed at 1 site in United States. Open to female participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-07-21.

Sponsored by Summa Health System · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
20 Years to 85 Years
Sex
Female
01

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.

02

Conditions studied

  • Obstructive Sleep Apnea
  • Bariatric Surgery
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's planned enrollment of 20 is below the median of 106 across 386 observational studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Summa Health System is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Obese women, 20 - 85 years of age

Inclusion criteria

  • obese (Body Mass Index > 35)
  • pending laparoscopic roux-en-Y gastric bypass at Summa Bariatric Care Center
  • women
  • ages 20 - 85
  • diagnosed OSA and prescribed nocturnal, autotitrating positive airway pressure therapy

Exclusion criteria

Exclusion Criteria:

  • are excluded if failure to meet any of the above
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
06

Study locations

1 site
  • Summa Health System Akron City Hospital
    Akron, Ohio 44304, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01243463
Lead sponsor
Summa Health System
First posted
Nov 18, 2010
Start date
Feb 2010
Last update
Jul 21, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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