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Novel by Upper Airway Respiratory Muscle Training to Treat OSA in Chronic SCI

NCT03664765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-03-12

Study results available
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Summary

It is estimated that spinal cord injury (SCI) affects approximately 12,000 new individuals every year in the United States, with the majority are cervical and/or upper thoracic injuries. Despite this high prevalence of obstructive sleep apnea (OSA) in chronic SCI population minority of patients are treated and are adherent to standard therapy (CPAP). This proposal addresses a new therapeutic intervention for OSA in SCI. The investigators hypothesized that combined oropharyngeal and respiratory muscle exercises improve respiratory symptoms and alleviate OSA in patients with chronic SCI. The investigators will perform a pilot randomized, sham-controlled study to examine the impact of combined daily exercises (\~30 min) for 1 and 3 months durations among Veterans with SCI. The investigators believe that this novel approach to treating OSA and will yield significant new knowledge that improves the health and quality of life of these patients.

Conditions

  • OSA
  • SCI/D
  • Upper Airway Exercise

Interventions

OTHER

UA and RMT

daily oropharyngeal and respiratory muscle exercises

OTHER

Sham exercise

Daily sham exercises

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Abdulghani Sankari, MD PhD · John D. Dingell VA Medical Center, Detroit, MI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03664765 on ClinicalTrials.gov