Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
13 participants
INTERVENTIONAL
2025-05-27
2025-12-01
Brief Summary
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Detailed Description
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Flow-adjusted end-tidal oxygen (PetO2) and carbon dioxide (PetCO2) will be assessed to determine the magnitude of hypoxic load during both wakefulness and sleep. To systematically assess these conditions, the conditions were defined as follows:
* 5A: 35 L/s exhaust flow with 5 cmH₂O PAP
* 5B: 23 L/s exhaust flow with 5 cmH₂O PAP
* 5C: 18 L/s exhaust flow with 5 cmH₂O PAP
* 5D: 13 L/s exhaust flow with 5 cmH₂O PAP
* 5E: 8 L/s exhaust flow with 5 cmH₂O PAP
* 0P: 35 L/s exhaust flow with 0 cmH₂O PAP
* 10A: 35 L/s exhaust flow with 10 cmH₂O PAP
* 10B: 23 L/s exhaust flow with 10 cmH₂O PAP
* 10C: 18 L/s exhaust flow with 10 cmH₂O PAP
* 10D: 13 L/s exhaust flow with 10 cmH₂O PAP
* 10E: 8 L/s exhaust flow with 10 cmH₂O PAP Primary endpoint is to evaluate the effect of exhaust flow on flow-adjusted average inspired oxygen fraction (FiO₂) during (1) wakefulness and (2) sleep between 5B vs. 5D.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
Subjects will receive randomized sequences of 11 conditions (varying in exhaust flow and PAP levels) during the evening and sleep portions of the night.
OTHER
SINGLE
Study Groups
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5 cmH2O with 35L/s
35 L/s exhaust flow with 5 cmH₂O PAP
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
5 cmH2O with 23L/s
23 L/s exhaust flow with 5 cmH₂O PAP
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
5 cmH2O with 18L/s
18 L/s exhaust flow with 5 cmH₂O PAP
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
5 cmH2O with 13L/s
13 L/s exhaust flow with 5 cmH₂O PAP
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
5 cmH2O with 8L/s
8 L/s exhaust flow with 5 cmH₂O PAP
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
0 cmH2O with 35L/s
35 L/s exhaust flow with 0 cmH₂O PAP
Mask exhaust port flow
Subjects will be administered varying levels of exhaust flow: 35, 23, 18, 13 and 8 L/s
10 cmH2O with 35L/s
35 L/s exhaust flow with 10 cmH₂O PAP
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
10 cmH2O with 23L/s
23 L/s exhaust flow with 10 cmH₂O PAP
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
10 cmH2O with 18L/s
18 L/s exhaust flow with 10 cmH₂O PAP
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
10 cmH2O with 13L/s
13 L/s exhaust flow with 10 cmH₂O PAP
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
10 cmH2O with 8L/s
8 L/s exhaust flow with 10 cmH₂O PAP
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
70 Years
ALL
No
Sponsors
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Sleep Res, Inc.
UNKNOWN
Brigham and Women's Hospital
OTHER
Responsible Party
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Atqiya Aishah, Ph.D.
Postdoctoral Research Fellow
Principal Investigators
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Atqiya Aishah, PhD
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School & Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025P000798
Identifier Type: -
Identifier Source: org_study_id
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