- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02830074
Treatment of Sleep-disordered Breathing in Patients With SCI
Does Treatment of Sleep-Disordered Breathing Improve Functional Outcomes in SCI
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- John D. Dingell VA Medical Center, Detroit, MI
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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)
|
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.
|
This program includes non-directive sleep education plus standard treatment of SDB.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
90 days
|
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 |
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
90 days
|
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. |
90 days
|
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. |
90 days
|
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. |
90 days
|
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. |
90 days
|
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
|
90 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: M S Badr, MD, John D. Dingell VA Medical Center, Detroit, MI
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Wounds and Injuries
- Trauma, Nervous System
- Multiple Sclerosis
- Sleep Apnea Syndromes
- Respiratory Aspiration
- Spinal Cord Diseases
- Spinal Cord Injuries
Other Study ID Numbers
- B2116-R
- IRX002116A (Other Grant/Funding Number: VA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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