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 :
Completed
First Posted : September 10, 2018
Last Update Posted : March 8, 2022
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Condition or disease | Intervention/treatment | Phase |
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OSA SCI/D Upper Airway Exercise | Other: UA and RMT Other: Sham exercise | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 29 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 |
Actual Primary Completion Date : | February 28, 2022 |
Actual Study Completion Date : | February 28, 2022 |

Arm | Intervention/treatment |
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Active Comparator: Intervention exercise arm
daily oropharyngeal and respiratory muscle exercises
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Other: UA and RMT
daily oropharyngeal and respiratory muscle exercises |
Sham Comparator: Control arm
Daily sham exercises
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Other: Sham exercise
Daily sham exercises |
- 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.
- Change in sleep quality [ Time Frame: 3 months ]To measure the change in subjective sleep quality using the Pittsburgh sleep quality index (PSQI) questionnaire.
- Change in sleep apnea severity [ Time Frame: 3 months ]The sleep measures will use the Apnea hypopnea index (AHI)

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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 |
Inclusion Criteria:
- Adult patients with chronic SCI/D (>6 months post-injury)
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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:
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Receiving continuous mechanical ventilation
- except PAP therapy which is considered usual treatment for SDB)
- Severe congestive heart failure with ejection fraction <35%
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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

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
United States, Michigan | |
John D. Dingell VA Medical Center, Detroit, MI | |
Detroit, Michigan, United States, 48201 |
Principal Investigator: | Abdulghani Sankari, MD PhD | John D. Dingell VA Medical Center, Detroit, MI |
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: | March 8, 2022 |
Last Verified: | March 2022 |
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 |
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 |
OSA SCI/D RMT Upper airway exercise |