Assessment of Circuit Rebreathing During CPAP Therapy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07062770
Status
Recruiting
Apply to this trial

Conditions

  • Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Continuous positive airway pressure (CPAP) — DEVICE
    Subjects will be administered either 0, 5 or 10 cmH2O
  • Mask exhaust port flow — OTHER
    Subjects will be administered varying levels of exhaust flow: 35, 23, 18, 13 and 8 L/s

Study Details

The goal of this research is to better understand how different CPAP mask designs affect airflow and rebreathing of exhaled carbon dioxide (CO₂) during sleep in individuals with obstructive sleep apnea (OSA).

Key Dates

Start date
May 27, 2025
Status verified
Jul 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
13 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: 5 cmH2O with 35L/s
    35 L/s exhaust flow with 5 cmH₂O PAP
  • Experimental: 5 cmH2O with 23L/s
    23 L/s exhaust flow with 5 cmH₂O PAP
  • Experimental: 5 cmH2O with 18L/s
    18 L/s exhaust flow with 5 cmH₂O PAP
  • Experimental: 5 cmH2O with 13L/s
    13 L/s exhaust flow with 5 cmH₂O PAP
  • Experimental: 5 cmH2O with 8L/s
    8 L/s exhaust flow with 5 cmH₂O PAP
  • Placebo Comparator: 0 cmH2O with 35L/s
    35 L/s exhaust flow with 0 cmH₂O PAP
  • Experimental: 10 cmH2O with 35L/s
    35 L/s exhaust flow with 10 cmH₂O PAP
  • Experimental: 10 cmH2O with 23L/s
    23 L/s exhaust flow with 10 cmH₂O PAP
  • Experimental: 10 cmH2O with 18L/s
    18 L/s exhaust flow with 10 cmH₂O PAP
  • Experimental: 10 cmH2O with 13L/s
    13 L/s exhaust flow with 10 cmH₂O PAP
  • Experimental: 10 cmH2O with 8L/s
    8 L/s exhaust flow with 10 cmH₂O PAP

Primary Outcome Measure

Change in flow-adjusted average inspired oxygen fraction (FiO₂) during wake. [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Atqiya Aishah, PhD
[email protected]
857 396 3808
Scott A Sands, PhD
[email protected]
617 278 0911

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

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