Novel Treatment of Sleep Apnea by Upper Airway and Respiratory Muscle Training
Phase: NA
Conditions: OSA, SCI/D, Upper Airway Exercise
Sponsor: VA Office of Research and Development

Novel by Upper Airway Respiratory Muscle Training to Treat OSA in Chronic SCI 
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NCT03664765  
Abdulghani Sankari, MD, PhD  
8/7/2023  
 
 

 
Study Protocol: This pilot/feasibility study randomized 24 Veterans with SCI/D and OSA to receive 3 
months of daily treatment with a validated set of oropharyngeal and RMT (intervention arm) versus 
sham therapy (control arm). All enrolled participants completed sleep-related questionnaires, 
pulmonary function testing, tongue strength (Fmax) and fatigability (T-50) assessment at night-time and 
in the morning after sleep, and maximal inspiratory and expiratory muscle force assessment. At the end 
of three months, participants underwent sleep-related questionnaires, pulmonary function testing, and 
Fmax, T50, and respiratory muscle force measurement and each participant in the treatment arm 
underwent a semi-structured telephone interview, asked about issues related to acceptability of 
intervention.  
Statistical Data Analysis: One of the pre-specified primary outcome was the recruitment rate, calculated 
as the proportion of those invited to fill in a screening questionnaire that consent to the trial. The 
practicalities of recruitment was assessed descriptively. Refusal and dropout from the study protocol 
were recorded. The feasibility, acceptability, and appropriateness of data collection strategies were 
assessed descriptively and through item response rates. Data were collected and overall screening rates, 
eligibility rates (e.g., rates of OSA, CSA, and SCI/D levels) were calculated, written informed consent 
rates, randomization rates, intervention completion rates, and attrition rates. The acceptability and 
feasibility of combined oropharyngeal and RMT were assessed by a short semi-structured telephone 
interview which was conducted with all study participants after completion of study during which they 
were be asked how they felt about the processes of recruitment and randomization. The content of the 
semi-structured interviews was summarized and potential modifications to the oropharyngeal and RMT 
intervention were identified.