RECRUITING

Mild Intermittent Hypoxia and Its Multipronged Effect on Sleep Apnea

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-11-15
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03736382

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body mass index \< 40 kg/m\^2.
  2. * 18 to 60 years old.
  3. * Newly diagnosed sleep apnea (i.e. apnea/hypopnea index \< 100 events per hour - average nocturnal oxygen saturation \> 85 %) that has not been treated.
  4. * Diagnosed with prehypertension or Stage 1 hypertension as categorized by the American Heart Association
  5. * Not pregnant.
  6. * Normal lung function.
  7. * Minimal alcohol consumption (i.e. no more than the equivalent of a glass of wine/day)
  8. * A typical sleep/wake schedule (i.e. participants will not be night shift workers or have recently travelled across time zones).
  9. * 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.
  1. * Any disease other than high blood pressure and sleep apnea.
  2. * Medications for high blood pressure and sleep promoting supplements including melatonin
  3. * Current effective CPAP usage (greater than 4 hours per night).
  4. * Night Shift workers or recently traveled across time zones.

Contacts and Locations

Study Contact

Jason H Mateika, Ph.D.
CONTACT
313-576-4481
am1819@wayne.edu
Shipra Puri, Ph.D.
CONTACT
313-576-4414
shiprapuri@wayne.edu

Principal Investigator

Jason H Mateika, Ph.D.
PRINCIPAL_INVESTIGATOR
Wayne State University

Study Locations (Sites)

John D Dingell VA Medical Center
Detroit, Michigan, 48201
United States
Wayne State University
Detroit, Michigan, 48201
United States

Collaborators and Investigators

Sponsor: Wayne State University

  • Jason H Mateika, Ph.D., PRINCIPAL_INVESTIGATOR, Wayne State University

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

Study Start Date2018-11-15
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2018-11-15
Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

  • Mild Intermittent Hypoxia
  • Continuous positive airway pressure therapy

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea
  • Spinal Cord Injuries