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Treatment of Sleep-disordered Breathing in Patients With SCI

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ClinicalTrials.gov Identifier: NCT02830074
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : May 21, 2019
Sponsor:
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)
Estimated Enrollment : 74 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
Estimated Primary Completion Date : September 30, 2019
Estimated 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 ]
    PAP adherence will be monitored remotely using existing data gathering systems. This will be summarized into the proportion of nights (out of 90 nights) with use >4 hours. The investigators will also examine mean hours of nightly use for each participant over the 90-day intervention period. The investigators have experience using these procedures in other studies and this process has resulted in data loss rates <10% for PAP use. The proportion of nights each month (out of 30 nights) with use >4 hours will be used as the main independent measure of PAP use. Remote monitoring of nightly PAP use

  2. Subjective Sleep Quality [ 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.

  3. Quality of life [ Time Frame: 90 days ]
    The investigators will use the WHO-QOL BREF questionnaire. This is a 26-item version of the WHOQOL-100, and is frequently used as an outcome measure in clinical trials. 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 SCI/D 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.

  4. subjective sleep quality [ Time Frame: 90 days ]
    Sleep diaries will be completed for 1 week before the laboratory PSG, and again at the 3-month follow-up assessments. The investigators will use a diary based on the AASM Consensus Sleep Diary, with items added to track sleep medication use, and self-reported PAP use. The diary will be used to compute self-reported sleep efficiency (time asleep out of time in bed), hours of sleep, time to fall asleep, time awake at night, and number of awakenings. This will be used as an measure of sleep quality. Participants who cannot complete a paper diary will be provided with a phone number to call to report diary information each morning


Secondary Outcome Measures :
  1. The Spinal Cord Independence Measure-Self Report (SCIM-SR) [ Time Frame: 90 days ]
    The Spinal Cord Independence Measure-Self Report (SCIM-SR) will be used to evaluate performance of activities of daily living. The SCIM-SR is a self-report version of the SCIM III, a reliable and valid measure of global disability for patients with SCI/D. The SCIM-SR has 3 subscales: self-care, respiration and sphincter management, and mobility. Scores range from 0-100 and higher scores reflect greater independence. Since some individuals' in the study will require the assistance of family members or caregivers, for descriptive purposes the investigators will also ask an individual familiar with the patient's level of functioning to complete the SCIM if the patient gives permission for us to do so. The SCIM-SR total and subscales scores (as completed by the patient) will be used as the functional status outcome measure

  2. 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

  3. 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 has high internal consistency (.91), can discriminate good vs. poor sleepers (p<.0001) and is sensitive to change over time. The FSS is sensitive to change after sleep-related interventions as well. The FSS total score will be used as an outcome measure

  4. 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 MIP as the key outcome measures for respiratory function for this study, as these are the most representative of respiratory functioning during sleep.



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

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


Contacts
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Contact: M S Badr, MD (313) 374-2038 m.badr@va.gov

Locations
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United States, Michigan
John D. Dingell VA Medical Center, Detroit, MI Recruiting
Detroit, Michigan, United States, 48201
Contact: Edi Levi, MD    (313) 576-4451    edi.levi@va.gov   
Contact: Erin Olgren, PhD MS    (313) 576-4448    erin.olgren@va.gov   
Principal Investigator: M Safwan Badr, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: M Safwan Badr, MD John D. Dingell VA Medical Center, Detroit, MI

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02830074     History of Changes
Other Study ID Numbers: B2116-R
IRX002116A ( Other Grant/Funding Number: VA )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
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
Sleep
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
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders