Effects of mild intermittent hypoxia on sleep apnea treatment
Mild Intermittent Hypoxia and CPAP: A Multi-pronged Approach to Treat Sleep Apnea in Intact and Spinal Cord Injured Humans
This study is testing if mild oxygen deprivation can help people with sleep apnea and spinal cord injuries breathe better while using CPAP therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Wayne State University Academic / other |
| Locations | 2 sites (Detroit, Michigan and 1 other locations) |
| Trial ID | NCT03736382 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of mild intermittent hypoxia (IH) on patients with obstructive sleep apnea and spinal cord injuries. The approach involves exposing participants to mild IH to enhance upper airway muscle activity, potentially improving the effectiveness of continuous positive airway pressure (CPAP) therapy. By promoting respiratory plasticity, the study aims to increase compliance with CPAP and reduce associated comorbidities. Participants will be monitored for changes in sleep apnea severity and overall health outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 60 with newly diagnosed sleep apnea and prehypertension or Stage 1 hypertension.
Not a fit: Patients with severe comorbid conditions or those currently on medications for high blood pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve CPAP compliance and reduce health complications associated with sleep apnea.
How similar studies have performed: While the concept of mild IH is relatively novel, some studies have indicated potential benefits, suggesting this approach may yield promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body mass index \< 40 kg/m\^2. * 18 to 60 years old. * Newly diagnosed sleep apnea (i.e. apnea/hypopnea index \< 100 events per hour - average nocturnal oxygen saturation \> 85 %) that has not been treated. * Diagnosed with prehypertension or Stage 1 hypertension as categorized by the American Heart Association * Not pregnant. * Normal lung function. * Minimal alcohol consumption (i.e. no more than the equivalent of a glass of wine/day) * A typical sleep/wake schedule (i.e. participants will not be night shift workers or have recently travelled across time zones). * For spinal cord injured participants (Aim-2): incomplete spinal cord lesions at C3 or below and above T12 (greater than 36 mos. post-SCI) without joint contractures but with signs of voluntary ankle, knee and hip movements and the ability to ambulate at least one step without human assistance. Exclusion Criteria: * Any disease other than high blood pressure and sleep apnea. * Medications for high blood pressure and sleep promoting supplements including melatonin * Current effective CPAP usage (greater than 4 hours per night). * Night Shift workers or recently traveled across time zones.
Where this trial is running
Detroit, Michigan and 1 other locations
- John D Dingell VA Medical Center — Detroit, Michigan, United States (Recruiting)
- Wayne State University — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Jason H Mateika, Ph.D. — Wayne State University
- Study coordinator: Jason H Mateika, Ph.D.
- Email: am1819@wayne.edu
- Phone: 313-576-4481
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.