Mild Intermittent Hypoxia and CPAP: A Multi-pronged Approach to Treat Sleep Apnea in Intact and Spinal Cord Injured Humans

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
John D Dingell VA Medical Center
RECRUITING
Detroit
Wayne State University
RECRUITING
Detroit
Contact Information
Primary
Jason H Mateika, Ph.D.
am1819@wayne.edu
313-576-4481
Backup
Shipra Puri, Ph.D.
shiprapuri@wayne.edu
313-576-4414
Time Frame
Start Date: 2018-11-15
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 40
Treatments
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.
Sponsors
Leads: Wayne State University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov