Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT03736382

Mild Intermittent Hypoxia and Its Multipronged Effect on Sleep Apnea

Led by Wayne State University · Updated on 2024-07-19

40

Participants Needed

2

Research Sites

367 weeks

Total Duration

On this page

Sponsors

W

Wayne State University

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Mild Intermittent Hypoxia and Its Multipronged Effect on Sleep Apnea

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Body mass index < 40 kg/m²
  • Age between 18 and 60 years
  • Newly diagnosed sleep apnea with apnea/hypopnea index < 100 events per hour and average nocturnal oxygen saturation > 85%
  • Diagnosed with prehypertension or Stage 1 hypertension as defined by the American Heart Association
  • Not pregnant
  • Normal lung function
  • Minimal alcohol consumption (no more than one glass of wine per day)
  • Typical sleep/wake schedule (not night shift workers or recent travelers across time zones)
  • For spinal cord injured participants: incomplete spinal cord lesions at C3 or below and above T12, greater than 36 months post-injury, no joint contractures, with voluntary ankle, knee, and hip movements, and able to take at least one step without human assistance
Not Eligible

You will not qualify if you...

  • Any disease other than high blood pressure and sleep apnea
  • Taking medications for high blood pressure or sleep-promoting supplements including melatonin
  • Current effective CPAP use of more than 4 hours per night
  • Night shift workers or recent travelers across time zones

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

John D Dingell VA Medical Center

Detroit, Michigan, United States, 48201

Actively Recruiting

2

Wayne State University

Detroit, Michigan, United States, 48201

Actively Recruiting

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Research Team

J

Jason H Mateika, Ph.D.

CONTACT

S

Shipra Puri, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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