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Treatment of Sleep-disordered Breathing in Patients With SCI

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ClinicalTrials.gov Identifier: NCT02830074
Recruitment Status : Completed
First Posted : July 12, 2016
Results First Posted : April 22, 2021
Last Update Posted : May 19, 2021
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Sleep-disordered Breathing Spinal Cord Disease Multiple Sclerosis Behavioral: Best practices PAP + patient Education +ongoing Support and Training Behavioral: Sleep Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Treatment of Sleep-Disordered Breathing Improve Functional Outcomes in SCI
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: The BEST Program
a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)
Behavioral: Best practices PAP + patient Education +ongoing Support and Training
This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training

Active Comparator: Sleep Education and standard SDB treatment
This program includes non-directive sleep education plus standard treatment of SDB.
Behavioral: Sleep Education
This program includes non-directive sleep education plus standard treatment of SDB.

Primary Outcome Measures :
  1. PAP Adherence [ Time Frame: 90 days ]
    Number of nights positive airway pressure (PAP) was used >=4 hours during the first 90 days measured by remote monitoring. Scores range from 0 to 90 days. Higher scores indicate better outcome.

  2. Subjective Sleep Quality Was Measured by The Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 90 days ]

    The Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire that assesses sleep quality and disturbances over the past month. The PSQI is sensitive for distinguishing normal and abnormal sleepers and has good test-retest reliability. The investigators will use the 3-factor scoring, which has been shown to have superior psychometric properties. This will be used as the main independent measure of sleep quality.

    The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality

Secondary Outcome Measures :
  1. Quality of Life Was Measured by WHO-QOL BREF Questionnaire [ Time Frame: 90 days ]
    The questionnaire is composed of four domains: physical health, psychological health, social relationships and environment. It also includes one question on overall quality of life and one on general health. Importantly, items on this scale are not dependent on mobility, which is unlikely to change in patients with Spinal Cord Injury/Disease as a result of improved sleep. The WHOQOL-BREF scores correlate highly (.89 or above) with WHOQOL-100 scores, and demonstrate good discriminant validity, content validity, internal consistency and test-retest reliability. The four WHOQOL-BREF domain scores will be used as main outcome measure. The WHOQOL-BREF measures quality of life across 4 domains. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval, higher score correspond to greater perceived quality of life

  2. Respiratory Function: Spirometry and Respiratory Muscle Force [ Time Frame: 90 days ]

    Spirometry is a simple bedside test used to evaluate lung function. Key spirometry values include forced vital capacity (FVC) and forced expiratory volume over 1 second (FEV1) and the absolute FEV1/FVC ratio. If the FVC and FEV1 are decreased, the absolute FEV1/FVC ratio distinguishes between obstructive and restrictive impairments. A normal absolute FEV1/FVC ratio suggest that restrictive ventilatory impairment may be present, and a reduced FEV1 and absolute FEV1/FVC ratio indicates an obstructive ventilator pattern. The investigators will use supine FVC and maximal inspiratory pressure (MIP) as the key outcome measures for respiratory function for this study, as these are the most representative of respiratory functioning during sleep.

    The normal value for the FEV1/FVC ratio is above 0.75. Values lower than 0.70 are suggestive of airflow limitation with an obstructive pattern whilst in restrictive lung diseases, this ratio is normal or high.

  3. Functional Status Was Measured by CHART Questionnaire. [ Time Frame: 90 days ]

    The CHART is a measure of overall function. The scale is divided into five separate domain scores: Physical, Cognitive, Mobility, Occupation, and Social integration.

    Each of the five domains scored from 0-100. higher number indicates better outcome.

  4. Depressive Symptom Severity [ Time Frame: 90 days ]

    The Patient Health Questionnaire-9 (PHQ-9) is a 9-item depression module in the PHQ (a self-administered diagnostic instrument for common mental disorders) which is part of the Primary Care Evaluation of Mental Disorders (PRIME-MD) suite of evaluation tools. The PHQ-9 aligns to the DSM-IV diagnostic criteria for depression and is widely used to screen for depression across VA. The PHQ-9 total score will be used to measure depressive symptom severity as an outcome.

    As a severity measure, the PHQ-9 score can range from 0 to 27. Higher the value, worse the outcome.

  5. Fatigue Symptoms [ Time Frame: 90 days ]

    The Flinders Fatigue Scale (FFS) is a 7-item fatigue rating scale used to measure general symptoms of fatigue. The FFS total score will be used as an outcome measure.

    Total fatigue scores range from 0 to 31, with higher scores indicating greater fatigue.

  6. Epworth Sleepiness Scale [ Time Frame: 90 days ]
    The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that quantifies daytime sleepiness, with higher scores indicating increased daytime hypersomnolence The ESS is ranging from 0 to 24. higher scores indicate more sleepiness

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830074

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United States, Michigan
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: M S Badr, MD John D. Dingell VA Medical Center, Detroit, MI
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol  [PDF] April 4, 2019
Statistical Analysis Plan  [PDF] April 2, 2020
Informed Consent Form  [PDF] April 2, 2020

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02830074    
Other Study ID Numbers: B2116-R
IRX002116A ( Other Grant/Funding Number: VA )
First Posted: July 12, 2016    Key Record Dates
Results First Posted: April 22, 2021
Last Update Posted: May 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Sleep Apnea Syndromes
Spinal Cord Injuries
Quality of life
Additional relevant MeSH terms:
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Respiratory Aspiration
Sleep Apnea Syndromes
Multiple Sclerosis
Spinal Cord Injuries
Spinal Cord Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders