Mild Intermittent Hypoxia and Its Multipronged Effect on Sleep Apnea

Conditions

• Obstructive Sleep Apnea
• Spinal Cord Injuries

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Mild intermittent hypoxia — OTHER
  Participants will be exposed to twelve two minute episodes of mild intermittent hypoxia 5 days a week for 3 weeks.
• Sham protocol — OTHER
  Participants will be exposed to twelve two minute episodes of sham mild intermittent hypoxia (i.e. room air) 5 days a week for 3 weeks.
• Continuous positive airway pressure (CPAP) — OTHER
  All participants will be treated with CPAP each night for a duration of 3 weeks.

Study Details

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.

Key Dates

Start date

Nov 15, 2018

Status verified

Jul 2024

Primary completion

Jun 30, 2025

Completion

Nov 30, 2025

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Group
  The experimental group is comprised of participants with OSA and hypertension \[either able bodied (Aim 1) or with spinal cord injury (Aim 2)\] that will be treated with mild IH and CPAP. In the present proposal, the mild IH protocol will be administered during wakefulness each day for 15 days over a 3-week period to participants that will also be treated with CPAP during sleep. The mild IH protocol will be comprised of a 20-minute baseline period followed by exposure to twelve - two minute episodes of hypoxia \[partial pressure of end-tidal oxygen (PETO2) = 50 mmHg\]. Each episode will be interspersed with a 2-minute recovery period under normoxic conditions. The PETCO2 will be sustained 2 mmHg above baseline values for the last ten minutes of baseline and throughout the remainder of the protocol.
• Sham Comparator: Control Group
  The control group is comprised of hypertensive OSA participants \[either able bodied (Aim 1) or with spinal cord injury (Aim 2)\] that will be exposed to a sham protocol in addition to being treated with CPAP during sleep. The sham protocol will be administered during wakefulness for 15 days over a 3-week period. During the sham protocol the participants will be exposed to atmospheric levels of oxygen and carbon dioxide for the duration of the protocol.

Primary Outcome Measure

Change in blood pressure measured during quiet wakefulness over the 24 hour period following mild intermittent hypoxia and sham protocol [ Time Frame: Before and after 15 days of exposure to mild intermittent hypoxia or a sham protocol. ]

Central Contacts

• Jason H Mateika, Ph.D.
  313-576-4481
  [email protected]
• Shipra Puri, Ph.D.
  313-576-4414
  [email protected]

Locations (2)

Find similar trials in Detroit, MI

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