Treatment of Sleep-disordered Breathing in Patients With SCI



Status:Recruiting
Conditions:Insomnia Sleep Studies, Hospital, Neurology, Neurology, Orthopedic, Multiple Sclerosis
Therapuetic Areas:Neurology, Psychiatry / Psychology, Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - Any
Updated:11/24/2018
Start Date:May 1, 2017
End Date:April 30, 2019
Contact:M S Badr, MD
Email:m.badr@va.gov
Phone:(313) 374-2038

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Does Treatment of Sleep-Disordered Breathing Improve Functional Outcomes in SCI?

Sleep-disordered breathing (SDB) remains under-treated in individuals living with spinal cord
injuries and disorders (SCI/D). The investigators' aim is to test a program that addresses
challenges and barriers to positive airway pressure (PAP) treatment of SDB among patients
with SCI/D. The investigators anticipate that patients who receive this program will have
higher rates of PAP use and will demonstrate improvements in sleep quality, general
functioning, respiratory functioning and quality of life from baseline to 6 months follow up
compared to individuals who receive a control program. This work addresses critical
healthcare needs for patients with SCI/D and may lead to improved health and quality of life
for these patients.

This proposal aims to test the efficacy of a comprehensive approach to improving positive
airway pressure (PAP) therapy acceptance and adherence and sleep quality among patients with
SCI/D. The proposed study is very relevant to the mission of the VA in promoting optimal
health for all Veterans, including those with disabilities. To this end, this study is a
randomized controlled trial (RCT) comparing the efficacy of a combined sleep and PAP
adherence program, called the "BEST" program (Best practices PAP + patient Education +ongoing
Support and Training). The central aim of this proposal therefore is to test the efficacy
between two PAP adherence programs. The study has two main aims. First, the investigators aim
to test the efficacy of the educational program in improving adherence to PAP therapy for the
first 6 months of use (with data available for some subjects for up to 12 months). Second,
the investigators will evaluate the impact of the program on sleep quality and on three key
areas of function: general functioning (using measures specific to SCI/D patients),
respiratory functioning (via spirometry) and quality of life (assessed with measures
appropriate for use with patients having limited mobility) over the 3-month intervention
period. The investigators will also explore whether the intervention is more effective for
some subgroups of patients than others. The proposed work is very relevant to VA's patient
care mission, addressing a critical need for patients who suffer from disparity in access to
high quality care because of their disabilities. The investigators anticipate that the
investigators' work will yield significant new knowledge that improves the health and quality
of life for Veterans living with SCI/D.

Inclusion Criteria:

- Adult patients with chronic SCI/D (>3 months post injury)

- American Spinal Injury Association (ASIA) classification A-D (i.e., excluding those
with no evidence of a neurologic deficit based on ASIA classification).

Exclusion Criteria:

- Patients receiving mechanical ventilation

- already using PAP for SDB at optimal compliance

- A clinical contraindication that prevents PAP use.

- recent health event that may affect sleep, e.g.:

- CVA

- acute MI

- recent surgery or 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 (e.g., due to dementia)

- the investigators will offer to re-contact patients 90 days after a health event or
after 90 days of sobriety
We found this trial at
1
site
Detroit, Michigan 48201
Principal Investigator: M Safwan Badr, MD
Phone: (313) 576-4451
?
mi
from
Detroit, MI
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