Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Obstructive sleep apnea (OSA) is a highly prevalent disorder with adverse neurocognitive and cardio-metabolic outcomes. Continuous positive airway pressure (CPAP) is the gold standard therapeutic option to treat airway obstructions during sleep and thus, prevent its adverse cardiovascular and neurocognitive outcomes. Previous clinical trials, however, have largely failed to show a consistent impact of CPAP on these health outcomes. One of the main limitations of these trials may be the inadequate characterization of OSA and its acute physiological consequences. By characterizing OSA based on the apnea-hypopnea index (AHI), there is a potential risk of negative results. In this trial, the investigators intend to tackle this issue, by better characterization of OSA-related physiological consequences during sleep using physiologically driven metrics to capture the burden of OSA-related hypoxemia (hypoxic burden), autonomic response (heart rate burden), and sleep fragmentation (arousal burden).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• Adults aged 21-80 years.

• Participants with a previous diagnosis of moderate to severe obstructive sleep will be eligible to enroll and attend the baseline study. Patients with a total apnea-hypopnea index greater than 15 events/hr on the baseline study will be eligible for further participation.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Nkiru G Ujomu
nujomu@bwh.harvard.edu
617-732-8976
Backup
Kiley E Blodgett
keblodgett@bwh.harvard.edu
617-732-8976
Time Frame
Start Date: 2020-09-10
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 158
Treatments
Experimental: Positive Airway Pressure Device
All participants will receive PAP therapy
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov