Multiple Sclerosis, Sleep-disordered Breathing, Spinal Cord Disease, Spinal Cord Injury
Conditions
Keywords
Sleep Apnea Syndromes, Spinal Cord Injuries, Sleep, Quality of life
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.
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.
Interventions
BEHAVIORALBest 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
BEHAVIORALSleep Education
This program includes non-directive sleep education plus standard treatment of SDB.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PAP Adherence | 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. |
| Subjective Sleep Quality Was Measured by The Pittsburgh Sleep Quality Index (PSQI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Status Was Measured by CHART Questionnaire. | 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. |
| Depressive Symptom Severity | 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. |
| Quality of Life Was Measured by WHO-QOL BREF Questionnaire | 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 |
| Epworth Sleepiness Scale | 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 |
| Fatigue Symptoms | 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. |
| Respiratory Function: Spirometry and Respiratory Muscle Force | 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. |
Countries
United States
Participant flow
Recruitment details
73 Participants started the study and out of those 73 participants only 63 were randomized. Therefore, only 63 participants out of 73 were eligible to be randomized ( 1 ineligible, 3 withdraw, 3 passive withdraw, 2 AHI\<5, 1 Pilot).
Participants by arm
| Arm | Count |
|---|---|
| The BEST Program a combined sleep and PAP adherence program, called the ?BEST? program (Best practices PAP + patient Education + ongoing Support and Training)
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 | 32 |
| Sleep Education and Standard SDB Treatment This program includes non-directive sleep education plus standard treatment of SDB.
Sleep Education: This program includes non-directive sleep education plus standard treatment of SDB. | 31 |
| Total | 63 |
Baseline characteristics
| Characteristic | The BEST Program | Sleep Education and Standard SDB Treatment | Total |
|---|---|---|---|
| Age, Continuous | 61.63 years STANDARD_DEVIATION 10.02 | 59.80 years STANDARD_DEVIATION 10.44 | 60.73 years STANDARD_DEVIATION 10.18 |
| Apnea Hypopnea Index (AHI) | 30.19 events/hr STANDARD_DEVIATION 22.92 | 30.32 events/hr STANDARD_DEVIATION 24.87 | 30.25 events/hr STANDARD_DEVIATION 23.71 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 30 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 15 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 15 Participants | 31 Participants |
| Region of Enrollment United States | 32 Participants | 31 Participants | 63 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 29 Participants | 29 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 31 |
| other Total, other adverse events | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 |
Outcome results
Primary
PAP Adherence
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.
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The BEST Program | PAP Adherence | 22.03 nights | Standard Deviation 24.74 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | PAP Adherence | 18.54 nights | Standard Deviation 24.67 |
Primary
Subjective Sleep Quality Was Measured by The Pittsburgh Sleep Quality Index (PSQI)
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
Time frame: 90 days
Population: 63 were randomized, 60 participants were analyzed for the 90 day period, due to missing data on study forms
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The BEST Program | Subjective Sleep Quality Was Measured by The Pittsburgh Sleep Quality Index (PSQI) | 6.96 units on a scale | Standard Deviation 4.12 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Subjective Sleep Quality Was Measured by The Pittsburgh Sleep Quality Index (PSQI) | 9.1 units on a scale | Standard Deviation 4.97 |
Secondary
Depressive Symptom Severity
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.
Time frame: 90 days
Population: 63 were randomized, 62 participants were analyzed for the 90 day period, due to missing data on study forms
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The BEST Program | Depressive Symptom Severity | 5.03 units on a scale | Standard Deviation 5.89 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Depressive Symptom Severity | 8.38 units on a scale | Standard Deviation 6.44 |
Secondary
Epworth Sleepiness Scale
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
Time frame: 90 days
Population: 63 were randomized, 62 participants were analyzed for the 90 day period, due to missing data on study forms
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The BEST Program | Epworth Sleepiness Scale | 4.58 units on a scale | Standard Deviation 4.94 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Epworth Sleepiness Scale | 6.48 units on a scale | Standard Deviation 4.13 |
Secondary
Fatigue Symptoms
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.
Time frame: 90 days
Population: 63 were randomized, 62 participants were analyzed for the 90 day period, due to missing data on study forms
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The BEST Program | Fatigue Symptoms | 9.61 units on a scale | Standard Deviation 8.46 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Fatigue Symptoms | 12.12 units on a scale | Standard Deviation 9.33 |
Secondary
Functional Status Was Measured by CHART Questionnaire.
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.
Time frame: 90 days
Population: 63 were randomized, 62 participants were analyzed for the 90 day period, due to missing data on study forms
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The BEST Program | Functional Status Was Measured by CHART Questionnaire. | Cognitive | 70.70 units on a scale | Standard Deviation 23.9 |
| The BEST Program | Functional Status Was Measured by CHART Questionnaire. | Occupation | 48.98 units on a scale | Standard Deviation 31.39 |
| The BEST Program | Functional Status Was Measured by CHART Questionnaire. | Mobility | 82.20 units on a scale | Standard Deviation 19.64 |
| The BEST Program | Functional Status Was Measured by CHART Questionnaire. | Social integration | 79 units on a scale | Standard Deviation 23.64 |
| The BEST Program | Functional Status Was Measured by CHART Questionnaire. | Physical | 79.09 units on a scale | Standard Deviation 31.02 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Functional Status Was Measured by CHART Questionnaire. | Social integration | 66.80 units on a scale | Standard Deviation 29.42 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Functional Status Was Measured by CHART Questionnaire. | Physical | 82.70 units on a scale | Standard Deviation 31.39 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Functional Status Was Measured by CHART Questionnaire. | Cognitive | 78.83 units on a scale | Standard Deviation 22.44 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Functional Status Was Measured by CHART Questionnaire. | Mobility | 78.17 units on a scale | Standard Deviation 24.33 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Functional Status Was Measured by CHART Questionnaire. | Occupation | 38.90 units on a scale | Standard Deviation 33.76 |
Secondary
Quality of Life Was Measured by WHO-QOL BREF Questionnaire
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
Time frame: 90 days
Population: 63 were randomized, 62 participants were analyzed for the 90 day period, due to missing data on study forms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The BEST Program | Quality of Life Was Measured by WHO-QOL BREF Questionnaire | WHO-QOL phys | 60.13 units on a scale | Standard Deviation 21.37 |
| The BEST Program | Quality of Life Was Measured by WHO-QOL BREF Questionnaire | WHO-QOL psych | 69.22 units on a scale | Standard Deviation 14.69 |
| The BEST Program | Quality of Life Was Measured by WHO-QOL BREF Questionnaire | WHO-QOL Soc | 63.70 units on a scale | Standard Deviation 24.39 |
| The BEST Program | Quality of Life Was Measured by WHO-QOL BREF Questionnaire | WHO-QOL ENV | 74.09 units on a scale | Standard Deviation 12.66 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Quality of Life Was Measured by WHO-QOL BREF Questionnaire | WHO-QOL ENV | 69.75 units on a scale | Standard Deviation 18.4 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Quality of Life Was Measured by WHO-QOL BREF Questionnaire | WHO-QOL phys | 54.72 units on a scale | Standard Deviation 22.08 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Quality of Life Was Measured by WHO-QOL BREF Questionnaire | WHO-QOL Soc | 57.52 units on a scale | Standard Deviation 23.2 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Quality of Life Was Measured by WHO-QOL BREF Questionnaire | WHO-QOL psych | 62.90 units on a scale | Standard Deviation 19.64 |
Secondary
Respiratory Function: Spirometry and Respiratory Muscle Force
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.
Time frame: 90 days
Population: 63 were randomized, 60 participants were analyzed for the 90 day period, due to missing data on study forms.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The BEST Program | Respiratory Function: Spirometry and Respiratory Muscle Force | 3.38 ratio | Standard Deviation 1.04 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | Respiratory Function: Spirometry and Respiratory Muscle Force | 3.20 ratio | Standard Deviation 0.97 |