NOvel by Upper Airway Respiratory Muscle Training to Treat OSA in Chronic SCI
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 1/16/2019 |
| Start Date: | January 1, 2019 |
| End Date: | October 30, 2020 |
| Contact: | Abdulghani Sankari, MD PhD |
| Email: | Abdulghani.Sankari@va.gov |
| Phone: | (313) 576-1000 |
Novel Treatment of Sleep Apnea by Upper Airway and Respiratory Muscle Training
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.
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.
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.
(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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 >5/hour and/or >50%
of the AHI
We found this trial at
1
site
Detroit, Michigan 48201
Principal Investigator: Abdulghani Sankari, MD PhD
Phone: 313-576-4448
Click here to add this to my saved trials
