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NCT03736382 · ClinicalTrials.gov registry record · NA
Mild Intermittent Hypoxia and Its Multipronged Effect on Sleep Apnea
A NA study of Spinal Cord Injuries and Obstructive Sleep Apnea, sponsored by Wayne State University.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT03736382 is a NA study of Spinal Cord Injuries and Obstructive Sleep Apnea that is actively recruiting participants, run by Wayne State University. The registered enrollment target is 40 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (34% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03736382, a NA study of Spinal Cord Injuries and Obstructive Sleep Apnea, is actively recruiting participants, sponsored by Wayne State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (34% lower). The listed sponsor is Wayne State University, which has 163 total studies on file at ClinicalTrials.gov.
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.
NCT03736382 reports 2 study locations spanning 1 distinct geographic area - top geographies include Michigan.
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.
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).
Who is sponsoring clinical trial NCT03736382?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
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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