Novel by Upper Airway Respiratory Muscle Training to Treat OSA in Chronic SCI
Condition: OSA; SCI/D; Upper Airway Exercise
Study type: Interventional

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.
    

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.
    

Intervention name(s): UA and RMT; Sham exercise
Intervention type(s): Other; Other
Intervention description(s): daily oropharyngeal and respiratory muscle exercises; Daily sham exercises
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)
Primary purpose: Treatment
Keywords: OSA; SCI/D; RMT; Upper airway exercise