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NCT05558501 · ClinicalTrials.gov registry record · Phase 1
Intermittent Hypoxia-initiated Plasticity in Humans: A Multi-pronged Therapeutic Approach to Treat Sleep Apnea and Overlapping Co-morbidities
A Phase 1 study of Obstructive Sleep Apnea, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05558501: Recruiting Phase 1 study of Obstructive Sleep Apnea, sponsored by VA Office of Research and Development.
NCT05558501 is a Phase 1 study of Obstructive Sleep Apnea that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 60 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05558501, a Phase 1 study of Obstructive Sleep Apnea, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The prevalence of obstructive sleep apnea (OSA) is high in the United States and is a major health concern. This disorder is linked to numerous heart, blood vessel and nervous system abnormalities, along with increased tiredness while performing exercise likely because of a reduced blood supply to skeletal muscles. The gold standard treatment of OSA with continuous positive airway pressure (CPAP) in many cases does not lead to significant improvements in health outcomes because the recommended number of hours of treatment per night is often not achieved. Thus, development of novel treatments to eliminate apnea and lessen the occurrence of associated health conditions is important. The investigators will address this mandate by determining if repeated exposure to mild intermittent hypoxia (MIH) reduces heart and blood vessel dysfunction and tiredness/ fatigue experienced while exercise performance. The investigators propose that exposure to MIH has a multipart effect. MIH directly targets heart and blood vessel associated conditions, while simultaneously increasing upper airway stability and improving sleep quality. These modifications may serve to directly decrease breathing episodes and may also serve to improve usage of CPAP. Independent of its effect, MIH may serve as an adjunctive therapy which provides another path to reducing heart and blood vessel abnormalities that might ultimately result in improvements in exercise capacity and reverse performance fatigue in individuals with OSA.
Primary Outcome
Blood pressure measures over 24 hours will be obtained. Blood pressure will be measured every 20 minutes beginning on Sunday at 6 AM and ending Monday at 6 AM. Participants will wear an actigraph (Actiwatch Spectrum, Respironics) and record their activities in a journal to determine the arousal state (i.e., active wakefulness, quiet wakefulness and sleep) associated with each blood pressure measurement. The data will be separated into active-awake, rest-awake and sleep based on the activity log
Conditions Studied
Interventions
- OTHER Mild Intermittent Hypoxia
- OTHER Sham MIH
Study Locations (1)
Michigan
- John D. Dingell VA Medical Center, Detroit, MI - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT05558501 shows while recruiting
NCT05558501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Mild Intermittent Hypoxia is the first listed.
NCT05558501 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05558501 about?
NCT05558501 is a clinical study titled "Intermittent Hypoxia-initiated Plasticity in Humans: A Multi-pronged Therapeutic Approach to Treat Sleep Apnea and Overlapping Co-morbidities". The prevalence of obstructive sleep apnea (OSA) is high in the United States and is a major health concern. This disorder is linked to numerous heart, blood vessel and nervous system abnormalities, along with increased tiredness while performing exercise likely because of a reduced blood supply to s...
What is the current status of trial NCT05558501?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-01-01. Estimated completion is 2027-12-31.
What conditions does trial NCT05558501 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT05558501?
The interventions under investigation include: Mild Intermittent Hypoxia (OTHER), Sham MIH (OTHER).
Who is sponsoring clinical trial NCT05558501?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05558501 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05558501's enrollment target sits among peer trials
60 86th of 155 higher than 60 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
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