NCT01712269

Brief Summary

The central aim of this research project is to determine how the ever-growing problem of obesity in the western world contributes to the pathophysiology of obstructive sleep apnea (OSA). To complete this aim, the investigators will determine the impact of obesity on the mechanisms underlying OSA. This will be achieved by making physiological measurements of 4 physiological traits known to cause OSA as well as the patients sleep apnea severity, before and after weight-loss surgery (i.e. bariatric surgery).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

4.3 years

First QC Date

October 16, 2012

Last Update Submit

February 28, 2017

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (2)

  • Model prediction of absence/presence of OSA

    Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. These variables are measured using a single maneuver in which CPAP is dropped from an optimum to various suboptimum pressures during sleep. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual and predicts OSA presence/absence.

    Subjects will be assessed at baseline (pre-surgery)

  • Model prediction of absence/presence of OSA

    Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. These variables are measured using a single maneuver in which CPAP is dropped from an optimum to various suboptimum pressures during sleep. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual and predicts OSA presence/absence.

    Subjects will be assessed between 9-12 months post surgery

Secondary Outcomes (2)

  • Apnea-Hypopnea Index

    Subjects will be assessed at baseline (pre-surgery)

  • Apnea-Hypopnea Index

    Subjects will be assessed between 9-12 months post surgery

Study Arms (1)

Weight-loss (bariatric) surgery

EXPERIMENTAL

All subjects enrolled will undergo bariatric surgery to assist weight-loss

Procedure: Weight-loss (bariatric) surgery

Interventions

Weight-loss (bariatric) surgeryPROCEDURE

Subjects will undergo bariatric surgery which will assist weight loss

Weight-loss (bariatric) surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 - 65 years
  • BMI \> 35kg/m2
  • Scheduled for weight-loss surgery

You may not qualify if:

  • Previous history of bariatric surgery
  • Any serious medical condition (except controlled hypertension and diabetes)
  • Any sleep disorder except OSA (RLS, insomnia, etc.)
  • Use of medications known to affect sleep/arousal, breathing, or muscle physiology
  • Allergy to lidocaine or Afrin
  • History of current cigarette smoking or previous smoking history \>10 pack years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

  • Atul Malhotra, MD

    Brigham & Womens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 16, 2012

First Posted

October 23, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)