Clinical trial NCT02830074: Treatment of Sleep-disordered Breathing in Patients With SCI
Official title: Does Treatment of Sleep-Disordered Breathing Improve Functional Outcomes in SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Sleep-disordered Breathing
Spinal Cord Disease
Multiple Sclerosis
Keywords: Sleep Apnea Syndromes
Spinal Cord Injuries
Sleep
Quality of life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-07-12
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: PAP Adherence
timeFrame: 90 days
measure: Subjective Sleep Quality Was Measured by The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 90 days
Secondary outcomes:
measure: Quality of Life Was Measured by WHO-QOL BREF Questionnaire
timeFrame: 90 days
measure: Respiratory Function: Spirometry and Respiratory Muscle Force
timeFrame: 90 days
measure: Functional Status Was Measured by CHART Questionnaire.
timeFrame: 90 days
measure: Depressive Symptom Severity
timeFrame: 90 days
measure: Fatigue Symptoms
timeFrame: 90 days
measure: Epworth Sleepiness Scale
timeFrame: 90 days
Other outcomes:
Locations:
city: Detroit
country: United States
facility: John D. Dingell VA Medical Center, Detroit, MI
state: Michigan
Study officials:
affiliation: John D. Dingell VA Medical Center, Detroit, MI
name: M S Badr, MD
role: PRINCIPAL_INVESTIGATOR
References: