Trial Outcomes & Findings for Novel by Upper Airway Respiratory Muscle Training to Treat OSA in Chronic SCI (NCT NCT03664765)

NCT ID: NCT03664765

Last Updated: 2024-03-12

Results Overview

Assess the feasibility of completing intervention arm (upper airway and respiratory muscle training arm) verses sham arm.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2024-03-12

Participant Flow

Participants were recruited to the primary site at John D. Dingell VA Medical Center.

Of 188 screened, 29 participants were enrolled. Of the 29 enrolled, 24 started the study protocol.

Participant milestones

Measure	Intervention Exercise Arm daily oropharyngeal and respiratory muscle exercises UA and RMT: daily oropharyngeal and respiratory muscle exercises	Control Arm Daily sham exercises Sham exercise: Daily sham exercises
Overall Study STARTED	12	12
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Intervention Exercise Arm daily oropharyngeal and respiratory muscle exercises UA and RMT: daily oropharyngeal and respiratory muscle exercises	Control Arm Daily sham exercises Sham exercise: Daily sham exercises
Overall Study Withdrawal by Subject	4	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intervention Exercise Arm n=12 Participants daily oropharyngeal and respiratory muscle exercises UA and RMT: daily oropharyngeal and respiratory muscle exercises	Control Arm n=12 Participants Daily sham exercises Sham exercise: Daily sham exercises	Total n=24 Participants Total of all reporting groups
Age, Continuous	66.3 years STANDARD_DEVIATION 10.0 • n=5 Participants	64.8 years STANDARD_DEVIATION 7.7 • n=7 Participants	65.4 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: This measures the number of randomized participants who stayed active in the study long enough to complete the three month protocol.

Assess the feasibility of completing intervention arm (upper airway and respiratory muscle training arm) verses sham arm.

Outcome measures

Measure	Intervention Exercise Arm n=12 Participants daily oropharyngeal and respiratory muscle exercises UA and RMT: daily oropharyngeal and respiratory muscle exercises	Control Arm n=12 Participants Daily sham exercises Sham exercise: Daily sham exercises
Feasibility-Number of Participants Who Complete the Three-month Protocol	8 Participants	10 Participants

PRIMARY outcome

Timeframe: 3 years

Assess the recruitment rate of the study

Outcome measures

Measure	Intervention Exercise Arm n=80 Participants daily oropharyngeal and respiratory muscle exercises UA and RMT: daily oropharyngeal and respiratory muscle exercises	Control Arm Daily sham exercises Sham exercise: Daily sham exercises
Recruitment	29 Participants	—

Adverse Events

Intervention Exercise Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Abdulghani Sankari Principal Investigator

JOHN D DINGELL VA MEDICAL CENTER

Phone: 13135761000

Email: abdulghani.sankari@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place