Reversible Effect of Falling Ventilatory Drive in Drive-dependent OSA

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06091098
Status
Recruiting
Apply to this trial

Conditions

  • OSA

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Dynamic CO2 — OTHER
    2% inspired CO2 for 2-4 breaths
  • Sham CO2 — OTHER
    Air

Study Details

Obstructive sleep apnea (OSA) is a highly prevalent disorder that has major consequences for cardiovascular health, neurocognitive function, risk of traffic accidents, daytime sleepiness, and quality of life. For years, a "classic" model of OSA has been used to describe the disorder, which fails to capture it's complexity. Recently, a model for OSA called drive-dependent OSA was discovered be more prevalent in the OSA population. The drive-dependent subgroup benefits exclusively from increased ventilation, increased dilator muscle activity, and reduced event risk when drive spontaneously rises. This study seeks to provide direct evidence that reducing the loss of drive prevents the loss of ventilation, pharyngeal muscle activity, and thus the onset of OSA respiratory events, specifically in "drive-dependent" but not "classic" OSA. This will be achieved using CO2 delivered at precise times during breaths in sleep to prevent loss of overall ventilatory drive.

Key Dates

Start date
Mar 27, 2024
Status verified
Mar 2025
Primary completion
Dec 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dynamic CO2 within Drive-Dependent OSA
    During sleep, before \~30 distinct respiratory events, we will administer \~2% CO2 for \~3-4 breaths.
  • Active Comparator: Dynamic CO2 within Classic OSA
    During sleep, before \~30 distinct respiratory events, we will administer \~2% CO2 for \~3-4 breaths.
  • Sham Comparator: Sham CO2 within Drive-Dependent OSA
    During sleep, Sham CO2 (air) will be administered for \~3-4 breaths before respiratory events.
  • Sham Comparator: Sham CO2 within Classic OSA
    During sleep, Sham CO2 (air) will be administered for \~3-4 breaths before respiratory events.

Primary Outcome Measure

Reduction in odds of respiratory event [ Time Frame: 1 night ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Scott SANDS, PhD
[email protected]

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

Related Studies