Treatment of Sleep-disordered Breathing in Patients With SCI

VA Office of Research and Development

Status: Completed

Conditions: Sleep-disordered Breathing; Multiple Sclerosis; Spinal Cord Disease; Spinal Cord Injury

Treatments: Behavioral: Best practices PAP + patient Education +ongoing Support and Training; Behavioral: Sleep Education

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02830074

IRX002116A (Other Grant/Funding Number)

B2116-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 2 patient groups

The BEST Program

Experimental group

Description:

a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)

Treatment:

Behavioral: Best practices PAP + patient Education +ongoing Support and Training

Sleep Education and standard SDB treatment

Active Comparator group

Description:

This program includes non-directive sleep education plus standard treatment of SDB.

Treatment:

Behavioral: Sleep Education