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Mild Intermittent Hypoxia and Its Multipronged Effect on Sleep Apnea
NCT03736382 · View on ClinicalTrials.gov ↗
Study Summary
Mild intermittent hypoxia (IH) initiates sustained increases in chest wall and upper airway muscle activity in humans. This sustained increase is a form of respiratory plasticity known as long-term facilitation (LTF). Repeated daily exposure to mild IH that leads to the initiation of LTF of upper airway muscle activity could lead to increased stability of the upper airway. In line with PI's laboratory's mandate to develop innovative therapies to treat sleep apnea, this increased stability could ultimately reduce the continuous positive airway pressure (CPAP) required to treat obstructive sleep apnea (OSA) and improve compliance with this gold standard treatment. Improved compliance could ultimately serve to mitigate those comorbidities linked to sleep apnea. Moreover, in addition to improving CPAP compliance numerous studies indicate that mild IH has many direct beneficial effects on cardiovascular, neurocognitive and metabolic function. Thus, mild IH could serve as a multipronged therapeutic approach to treat sleep apnea. In accordance with this postulation, our proposal will determine if repeated daily exposure to mild IH serves as an adjunct therapy coupled with CPAP to mitigate associated co-morbidities via its direct effects on a variety of cardiovascular, metabolic and neurocognitive measures and indirectly by improving CPAP compliance. Modifications in autonomic (i.e. sympathetic nervous system activity) and cardiovascular (i.e. blood pressure) function will be the primary outcome measures coupled to secondary measures of metabolic and neurocognitive outcomes.
Conditions Studied
Interventions
- OTHER Mild intermittent hypoxia
- OTHER Sham protocol
- OTHER Continuous positive airway pressure (CPAP)
Study Locations (2)
Michigan
- John D Dingell VA Medical Center — Detroit
- Wayne State University — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2025-11-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03736382
The ClinicalTrials.gov registry entry for NCT03736382 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wayne State University, which has 145 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 3 interventions — of which Mild intermittent hypoxia is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03736382 reports 2 study locations spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03736382 about?
NCT03736382 is a clinical study titled "Mild Intermittent Hypoxia and Its Multipronged Effect on Sleep Apnea". Mild intermittent hypoxia (IH) initiates sustained increases in chest wall and upper airway muscle activity in humans. This sustained increase is a form of respiratory plasticity known as long-term facilitation (LTF). Repeated daily exposure to mild IH that leads to the initiation of LTF of upper ai...
What is the current status of trial NCT03736382?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2018-11-15. Estimated completion is 2025-11-30.
What conditions does trial NCT03736382 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Obstructive Sleep Apnea. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03736382?
The interventions under investigation include: Mild intermittent hypoxia (OTHER), Sham protocol (OTHER), Continuous positive airway pressure (CPAP) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03736382?
This trial is sponsored by Wayne State University, which has 145 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03736382 being conducted?
This trial has 2 study locations across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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