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 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:
🦠 Obstructive Sleep Apnea 🦠 Spinal Cord Injuries
🗓️ Study Start (Actual) 15 November 2018
🗓️ Primary Completion (Estimated) 30 June 2025
✅ Study Completion (Estimated) 30 November 2025
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Detroit, Michigan, United States
📍 Detroit, Michigan, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 60 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 November 2018
  • First Submitted that Met QC Criteria 6 November 2018
  • First Posted 9 November 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 July 2024
  • Last Update Posted 19 July 2024
  • Last Verified July 2024