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

NCT03664765 | Completed Results

• 1 other identifier: B2885-P
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

OSA; SCI/D; Upper Airway Exercise

Keywords

OSA; SCI/D; RMT; Upper airway exercise

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention exercise arm

ACTIVE COMPARATOR

daily oropharyngeal and respiratory muscle exercises

Other: UA and RMT

Control arm

SHAM COMPARATOR

Daily sham exercises

Other: Sham exercise

Interventions

UA and RMT OTHER

daily oropharyngeal and respiratory muscle exercises

Intervention exercise arm

Sham exercise OTHER

Daily sham exercises

Control arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201, United States

Location

Limitations and Caveats

\- The sample size is small and the majority are males, therefore findings from this study may not be applicable to the general population

Results Point of Contact

• Title: Dr. Abdulghani Sankari Principal Investigator
• Organization: JOHN D DINGELL VA MEDICAL CENTER

abdulghani.sankari@va.gov

13135761000

Study Officials

• Abdulghani Sankari, MD PhD

  John D. Dingell VA Medical Center, Detroit, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized and blinded to the intervention arm (upper airway and respiratory muscle training arm) versus sham arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: January 1, 2019
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within one year of the publication

Locations

US (1)