Recruiting

CPAP Masks

Sponsor:

Brigham and Women's Hospital

Code:

NCT07062770

Conditions

Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Continuous positive airway pressure (CPAP)

Mask exhaust port flow

Study Details

Brief summary:

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).

Conditions

Obstructive Sleep Apnea (OSA)

Study ID

NCT07062770

Start date

May 27, 2025

Status verified date

Jul, 2025

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Moderate to severe OSA (AHI>20)
  • Self-reported CPAP users or have previously used CPAP
  • Self-reported holding pressure of maximum 13 cmH2O (if known)
  • Age: 21-70
  • BMI: 18-40 kg/m2

Exclusion Criteria:

  • Self-reported severe mouth-breathing
  • Requirement for nocturnal supplemental oxygen or other ventilatory support
  • Severe cardiovascular or pulmonary disease
  • Any unstable or acute medical condition
  • Any additional sleep disorder, including insomnia, except for OSA.

Study Design

Enrollment

13 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

Continuous positive airway pressure (CPAP)

Subjects will be administered either 0, 5 or 10 cmH2O

Mask exhaust port flow

Subjects will be administered varying levels of exhaust flow: 35, 23, 18, 13 and 8 L/s

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Atqiya Aishah, PhD

857 396 3808aaishah@bwh.harvard.edu

Scott A Sands, PhD

6172780911sasands@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Atqiya Aishah, PhD

857 396 3808aaishah@bwh.harvard.edu

Scott A Sands, PhD

617 278 0911sasands@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 14, 2025

Last verified

Jul, 2025

Keywords

  • Obstructive sleep apnea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-07-14.