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

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ClinicalTrials.gov Identifier: NCT03664765
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
Louis Stokes VA Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
OSA SCI/D Upper Airway Exercise Other: UA and RMT Other: Sham exercise Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled pilot trial to assess the feasibility of using combined oropharyngeal and respiratory muscle training versus sham training on OSA in patients with chronic SCI/D
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will be randomized and blinded to the intervention arm (upper airway and respiratory muscle training arm) versus sham arm
Primary Purpose: Treatment
Official Title: Novel Treatment of Sleep Apnea by Upper Airway and Respiratory Muscle Training
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 3 months ]
    Determine difference in recruitment rates in the intervention arm (upper airway and respiratory muscle training arm) and sham arm.


Secondary Outcome Measures :
  1. Change in sleep quality [ Time Frame: 3 months ]
    To measure the change in subjective sleep quality using the Pittsburgh sleep quality index (PSQI) questionnaire.

  2. Change in sleep apnea severity [ Time Frame: 3 months ]
    The sleep measures will use the Apnea hypopnea index (AHI)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 >5/hour and/or >50% of the AHI
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664765


Contacts
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Contact: Abdulghani Sankari, MD PhD (313) 576-1000 ext 63499 Abdulghani.Sankari@va.gov

Locations
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United States, Michigan
John D. Dingell VA Medical Center, Detroit, MI Recruiting
Detroit, Michigan, United States, 48201
Contact: Erin Olgren, PhD MS    313-576-4448    erin.olgren@va.gov   
Principal Investigator: Abdulghani Sankari, MD PhD         
Sponsors and Collaborators
VA Office of Research and Development
Louis Stokes VA Medical Center
Investigators
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Principal Investigator: Abdulghani Sankari, MD PhD John D. Dingell VA Medical Center, Detroit, MI
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03664765    
Other Study ID Numbers: B2885-P
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Within one year of the publication

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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
Keywords provided by VA Office of Research and Development:
OSA
SCI/D
RMT
Upper airway exercise