Novel by Upper Airway Respiratory Muscle Training to Treat OSA in Chronic SCI (NOURMT-OSA)

Novel Treatment of Sleep Apnea by Upper Airway and Respiratory Muscle Training

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.

Study Overview

• Status: Completed
• Conditions: OSA; SCI/D; Upper Airway Exercise
• Intervention / Treatment: Other: UA and RMT; Other: Sham exercise

Detailed Description

In recent years, the investigators and others have discovered that spinal cord injury/disease (SCI/D) is associated with significant increase in the sleep-disordered breathing (SDB) prevalence. Nearly 80% of patients with SCI/D including Veterans suffer from SDB after six months of injury (majority of them 70-80% are obstructive apneas and hypopneas-OSA). However, most patients SCI/D do not tolerate standard SDB treatment (continuous positive airway pressure-CPAP) leading to lack of compliance. Therefore, identifying other therapies is important for this common condition that is linked to poor outcome in the general population (heart disease, stroke, hypertension and poor cognition). It has been reported in sleep apnea able-bodied patients that oropharyngeal muscle exercises for 3 months using speech pathology techniques improve the severity of SDB. Furthermore, previous studies showed respiratory muscle training (RMT) is effective for increasing respiratory muscle strength in people with cervical SCI. However, the effect of combined oropharyngeal and RMT on OSA in patients with SCI is unknown.

The purpose of this application is to identify new therapeutic interventions for OSA treatment in Veterans with SCI/D. This application proposes for a pilot study to randomizing 30 Veterans with SCI/D and OSA to receive 3 months of daily (30 minutes) treatment with a validated set of oropharyngeal and RMT (intervention arm) versus sham therapy (control arm). There will be three specific aims to address the following hypotheses:

Specific Aim (1): To test recruitment rate and feasibility of a pilot intervention that includes combined oropharyngeal and RMT versus sham treatment in individuals with SCI/D.

Specific Aim (2): To test the acceptability and usability of combined oropharyngeal and RMT in individuals with SCI/D.

Specific Aim (3): To determine the effect size estimates for clinical endpoints and their associated variability at the end of treatment to calculate an appropriate sample size for an adequately powered clinical trial.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • John D. Dingell VA Medical Center, Detroit, MI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients with chronic SCI/D (>6 months post-injury)

• American Spinal Injury Association (ASIA) classification A-D who have evidence of OSA

  • excluding those with no evidence of a neurologic deficit based on ASIA classification
• Specifically, the study will target those with SCI/D and OSA who would like alternative treatment options or to have a lower PAP pressure, if they refused, or did not tolerate PAP treatment

Exclusion Criteria:

• Receiving continuous mechanical ventilation

  • except PAP therapy which is considered usual treatment for SDB)
• Severe congestive heart failure with ejection fraction <35%

• Recent health event that may affect sleep

  • stroke
  • acute myocardial infarction
  • recent surgery
  • hospitalization
• Alcohol or substance abuse (<90 days sobriety)
• Self-described as too ill to engage in study procedures
• Unable to provide self-consent for participation
• Central sleep apnea (CSA) defined as central apnea/hypopnea index >50% of the AHI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention exercise arm; daily oropharyngeal and respiratory muscle exercises	Other: UA and RMT; daily oropharyngeal and respiratory muscle exercises
Sham Comparator: Control arm; Daily sham exercises	Other: Sham exercise; Daily sham exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility-Number of Participants Who Complete the Three-month Protocol	Assess the feasibility of completing intervention arm (upper airway and respiratory muscle training arm) verses sham arm.	3 months
Recruitment	Assess the recruitment rate of the study	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep quality	To measure the change in subjective sleep quality using the Pittsburgh sleep quality index (PSQI) questionnaire.	3 months
Change in sleep apnea severity	The sleep measures will use the Apnea hypopnea index (AHI)	3 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Louis Stokes VA Medical Center
• Investigators: Principal Investigator: Abdulghani Sankari, MD PhD, John D. Dingell VA Medical Center, Detroit, MI

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: OSA; SCI/D; RMT; Upper airway exercise
• Other Study ID Numbers: B2885-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publications from research will be made available to the public through the national Library of Medicine PubMed within one year after the date of publication. Final data sets underlying all publications resulting form the proposed research will be shared outside if the following criteria is met: A limited Dataset will be created and shared pursuant to Data Use Agreement (DUA) appropriately limiting use for dataset and prohibiting the recipient from identifying or re-identifying any individuals whose data are included in the dataset.
• IPD Sharing Time Frame: Within one year of the publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No