NCT01243463

Brief 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 Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed
Last Updated

July 21, 2011

Status Verified

July 1, 2011

First QC Date

November 16, 2010

Last Update Submit

July 20, 2011

Conditions

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese women, 20 - 85 years of age

You may qualify if:

  • 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

You may not qualify if:

  • are excluded if failure to meet any of the above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Summa Health System Akron City Hospital

Akron, Ohio, 44304, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 18, 2010

Study Start

February 1, 2010

Last Updated

July 21, 2011

Record last verified: 2011-07

Locations