At a glance

ClinicalIndex Comparison Record

N/ACompleted· 73 enrolled

Drug / intervention

Best practices PAP + patient Education +ongoing Support and Training +1 morebehavioral

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02830074

NCT02830074N/ACompleted

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

VA Office of Research and Development·interventional·Posted Jul 12, 2016·Updated May 19, 2021

In Brief

A clinical study evaluating Best practices PAP + patient Education +ongoing Support and Training and Sleep Education for Spinal Cord Injury and 3 related conditions. Completed, enrolled 73 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSpinal Cord Injury, Sleep-disordered Breathing, Spinal Cord Disease, Multiple Sclerosis

CountriesUnited States

Collaborators--

Timeline

N/ACompletedFinished

2017201820192020202120222023202420252026

First PostedJul 2016

Enrollment StartMay 2017

Primary CompletionSep 2019

Study CompletionMar 2020

TodayJul 2026

First PostedJul 12, 2016

Enrollment StartMay 1, 2017

Primary CompletionSep 30, 2019

Study CompletionMar 30, 2020

TodayJul 2, 2026

Enrollment to primary: 2.4 yearsPosted 10.0 years ago

Interventions

Best practices PAP + patient Education +ongoing Support and Trainingbehavioral

This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training

Sleep Educationbehavioral

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