Assessment of Circuit Rebreathing During CPAP Therapy

NCT07062770 | Recruiting FDA Device

• 1 other identifier: 2025P000798
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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)

Keywords

Obstructive sleep apnea

Outcome Measures

Primary Outcomes (2)

• Change in flow-adjusted average inspired oxygen fraction (FiO₂) during wake.

  Difference in FiO2 between 23L/s vs 13L/s exhaust flow at 5 cmH2O PAP.

  through study completion, an average of 1 year

• Change in flow-adjusted average inspired oxygen fraction (FiO₂) during sleep.

  Difference in FiO2 between 23L/s vs 13L/s exhaust flow at 5 cmH2O PAP.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Impact on hypoxic burden during sleep.

  through study completion, an average of 1 year

Study Arms (11)

5 cmH2O with 35L/s

EXPERIMENTAL

35 L/s exhaust flow with 5 cmH₂O PAP

Device: Continuous positive airway pressure (CPAP); Other: Mask exhaust port flow

5 cmH2O with 23L/s

EXPERIMENTAL

23 L/s exhaust flow with 5 cmH₂O PAP

Device: Continuous positive airway pressure (CPAP); Other: Mask exhaust port flow

5 cmH2O with 18L/s

EXPERIMENTAL

18 L/s exhaust flow with 5 cmH₂O PAP

Device: Continuous positive airway pressure (CPAP); Other: Mask exhaust port flow

5 cmH2O with 13L/s

EXPERIMENTAL

13 L/s exhaust flow with 5 cmH₂O PAP

Device: Continuous positive airway pressure (CPAP); Other: Mask exhaust port flow

5 cmH2O with 8L/s

EXPERIMENTAL

8 L/s exhaust flow with 5 cmH₂O PAP

Device: Continuous positive airway pressure (CPAP); Other: Mask exhaust port flow

0 cmH2O with 35L/s

PLACEBO COMPARATOR

35 L/s exhaust flow with 0 cmH₂O PAP

Other: Mask exhaust port flow

10 cmH2O with 35L/s

EXPERIMENTAL

35 L/s exhaust flow with 10 cmH₂O PAP

Device: Continuous positive airway pressure (CPAP); Other: Mask exhaust port flow

10 cmH2O with 23L/s

EXPERIMENTAL

23 L/s exhaust flow with 10 cmH₂O PAP

Device: Continuous positive airway pressure (CPAP); Other: Mask exhaust port flow

10 cmH2O with 18L/s

EXPERIMENTAL

18 L/s exhaust flow with 10 cmH₂O PAP

Device: Continuous positive airway pressure (CPAP); Other: Mask exhaust port flow

10 cmH2O with 13L/s

EXPERIMENTAL

13 L/s exhaust flow with 10 cmH₂O PAP

Device: Continuous positive airway pressure (CPAP); Other: Mask exhaust port flow

10 cmH2O with 8L/s

EXPERIMENTAL

8 L/s exhaust flow with 10 cmH₂O PAP

Device: Continuous positive airway pressure (CPAP); Other: Mask exhaust port flow

Interventions

Continuous positive airway pressure (CPAP) DEVICE

Subjects will be administered either 0, 5 or 10 cmH2O

10 cmH2O with 13L/s; 10 cmH2O with 18L/s; 10 cmH2O with 23L/s; 10 cmH2O with 35L/s; 10 cmH2O with 8L/s; 5 cmH2O with 13L/s; 5 cmH2O with 18L/s; 5 cmH2O with 23L/s; 5 cmH2O with 35L/s; 5 cmH2O with 8L/s

Mask exhaust port flow OTHER

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

0 cmH2O with 35L/s; 10 cmH2O with 13L/s; 10 cmH2O with 18L/s; 10 cmH2O with 23L/s; 10 cmH2O with 35L/s; 10 cmH2O with 8L/s; 5 cmH2O with 13L/s; 5 cmH2O with 18L/s; 5 cmH2O with 23L/s; 5 cmH2O with 35L/s; 5 cmH2O with 8L/s

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Sleep Res, Inc.: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Atqiya Aishah, PhD

  Harvard Medical School & Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Atqiya Aishah, PhD

CONTACT

857 396 3808; aaishah@bwh.harvard.edu

Scott A Sands, PhD

CONTACT

6172780911; sasands@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The exhaust flow and PAP level conditions will be blinded for the participant.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Model Details: Subjects will perform 1 in-lab sleep study visit consisting of an evening wake session followed by an overnight sleep study. Subjects will receive randomized sequences of 11 conditions (varying in exhaust flow and PAP levels) during the evening and sleep portions of the night.

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: July 14, 2025
• Study Start: May 27, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)