Nasal Continuous Positive Airway Pressure (CPAP) in Chronic Fatigue and Sleep-disordered Breathing
Primary Purpose
Chronic Fatigue With OSA, Chronic Fatigue Syndrome With OSA
Status
Terminated
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Active CPAP is compared with sham CPAP as a control intervention.
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue With OSA
Eligibility Criteria
Inclusion Criteria:
- Patients primarily referred for disabling, unexpected fatigue.
- According to the Fukuda criteria, diagnostic work-up yields a final diagnosis of chronic fatigue (CF) or chronic fatigue syndrome (CFS).
- 18 <= age <= 65
- Polysomnography Test (PSG) demonstrates an apnea-hypopnea index (AHI) >=15, as evidence for obstructive sleep apnea (OSA).
- Female patient of childbearing potential (premenopausal female biologically capable of becoming pregnant) has a confirmed negative pregnancy test at the start of the Continuous Positive Airway Pressure (CPAP) trial and has to employ an acceptable method of birth control.
- Written, signed and dated informed consent must be obtained from each patient.
- Patient able to understand and follow the requirements of the study and to comply.
- Willing to abstain from taking any medication or treatment prohibited in the protocol.
Exclusion Criteria:
- Patients primarily referred for Excessive Daytime Sleepiness (EDS) or snoring.
- Fatigue that is explained by medical or psychiatric causes.
- 18 > age > 65
- Apnea-Hypopnea Index (AHI) < 15
- Body Mass Index (BMI) >= 40, calculated as weight(m)/(height (m))²
- Parasomnia
- Severe sleepiness with (Epworth Sleepiness Scale) ESS >= 16 (=15% of the Chronic fatigue syndrome (CFS) population)
- Tonsillar hypertrophy (Friedman grade III and IV tonsils)
- Signs of nasal obstruction, including chronic use of topical nasal drugs.
- Earlier CPAP treatment
- Physical and mental disability that compromises the normal use of CPAP
- CPAP intolerance
- Current use of sedative (benzodiazepine and non-benzodiazepine GABA-esgic agonist) or antidepressant medication for a time period inferior to 3 weeks.
- Female patient who is pregnant, lactating or has a positive pregnancy test result.
Sites / Locations
- Ghent University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Active/Sham CPAP
Arm Description
Outcomes
Primary Outcome Measures
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: baseline evaluation.
Baseline evaluation before treatment. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: first treatment + effect evaluation.
At the end of the first treatment: effect evaluation. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: second treatment + effect evaluation.
At the end of the second treatment: effect evaluation. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.
Secondary Outcome Measures
The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: baseline evaluation.
Before treatment: baseline evaluation. Polysomnography Test (PSG) , Multiple Sleep Latency Test (MSLT) and questionnaires ( Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study Short Form 36-item (MOS SF36)) are used.
The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: first treatment + effect evaluation.
At the end of the first treatment: effect evaluation. Polysomnography Test (PSG) , Multiple Sleep Latency Test (MSLT) and questionnaires ( Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study Short Form 36-item (MOS SF36)) are used.
The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: second treatment + effect evaluation.
At the end of the second treatment: effect evaluation. Polysomnography Test (PSG) , Multiple Sleep Latency Test (MSLT) and questionnaires ( Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study Short Form 36-item (MOS SF36)) are used.
Full Information
NCT ID
NCT01368718
First Posted
June 6, 2011
Last Updated
December 14, 2022
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT01368718
Brief Title
Nasal Continuous Positive Airway Pressure (CPAP) in Chronic Fatigue and Sleep-disordered Breathing
Official Title
The Effect of Nasal CPAP in Patients With Chronic Fatigue and Sleep-disordered Breathing
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
low inclusion and adherence rates
Study Start Date
October 2012 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 11, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic fatigue (CF) and chronic fatigue syndrome (CFS) are disabling disorders that may be induced or aggravated by underlying sleep disturbances. The relationship between sleep quality and fatigue is still not fully elucidated. To evaluate the effect of improved sleep quality on fatigue, a randomized controlled and cross-over trial with nasal continuous positive airway pressure (nCPAP) is carried out in patients who present with a primary complaint of chronic disabling fatigue and who are found to have an apnea-hypopnea index (AHI) >= 15 on polysomnography (PSG).
The aim of this study is to address the issue of Continuous Positive Airway Pressure-responsiveness regarding fatigue as a presenting symptom in CF and CFS patient with obstructive sleep apnea (OSA), in the absence of underlying medical or psychiatric illness. The answer to this question may shed further light on the enigmatic relationship between sleep and fatigue. We also want to investigate the Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population. Zero-hypothesis: there is no effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue With OSA, Chronic Fatigue Syndrome With OSA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active/Sham CPAP
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Active CPAP is compared with sham CPAP as a control intervention.
Intervention Description
Patients are randomized into active or control arm. After the first treatment, a washout period is installed,after which therapy is switched according to the cross-over protocol. A CPAP device consists of a unit that generates airflow, which is directed to the airway via a mask. With active CPAP, the generated airflow creates a positive pressure and prevents upper airway collapse. With sham CPAP, the generated airflow creates a very low pressure.
Primary Outcome Measure Information:
Title
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: baseline evaluation.
Description
Baseline evaluation before treatment. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.
Time Frame
At day 0
Title
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: first treatment + effect evaluation.
Description
At the end of the first treatment: effect evaluation. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.
Time Frame
Treatment takes 28 days after first evaluation
Title
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: second treatment + effect evaluation.
Description
At the end of the second treatment: effect evaluation. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.
Time Frame
Treatment takes 28 days after second evaluation
Secondary Outcome Measure Information:
Title
The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: baseline evaluation.
Description
Before treatment: baseline evaluation. Polysomnography Test (PSG) , Multiple Sleep Latency Test (MSLT) and questionnaires ( Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study Short Form 36-item (MOS SF36)) are used.
Time Frame
At day 0
Title
The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: first treatment + effect evaluation.
Description
At the end of the first treatment: effect evaluation. Polysomnography Test (PSG) , Multiple Sleep Latency Test (MSLT) and questionnaires ( Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study Short Form 36-item (MOS SF36)) are used.
Time Frame
Treatment takes 28 days after first evaluation
Title
The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: second treatment + effect evaluation.
Description
At the end of the second treatment: effect evaluation. Polysomnography Test (PSG) , Multiple Sleep Latency Test (MSLT) and questionnaires ( Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study Short Form 36-item (MOS SF36)) are used.
Time Frame
Treatment takes 28 days after second evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients primarily referred for disabling, unexpected fatigue.
According to the Fukuda criteria, diagnostic work-up yields a final diagnosis of chronic fatigue (CF) or chronic fatigue syndrome (CFS).
18 <= age <= 65
Polysomnography Test (PSG) demonstrates an apnea-hypopnea index (AHI) >=15, as evidence for obstructive sleep apnea (OSA).
Female patient of childbearing potential (premenopausal female biologically capable of becoming pregnant) has a confirmed negative pregnancy test at the start of the Continuous Positive Airway Pressure (CPAP) trial and has to employ an acceptable method of birth control.
Written, signed and dated informed consent must be obtained from each patient.
Patient able to understand and follow the requirements of the study and to comply.
Willing to abstain from taking any medication or treatment prohibited in the protocol.
Exclusion Criteria:
Patients primarily referred for Excessive Daytime Sleepiness (EDS) or snoring.
Fatigue that is explained by medical or psychiatric causes.
18 > age > 65
Apnea-Hypopnea Index (AHI) < 15
Body Mass Index (BMI) >= 40, calculated as weight(m)/(height (m))²
Parasomnia
Severe sleepiness with (Epworth Sleepiness Scale) ESS >= 16 (=15% of the Chronic fatigue syndrome (CFS) population)
Tonsillar hypertrophy (Friedman grade III and IV tonsils)
Signs of nasal obstruction, including chronic use of topical nasal drugs.
Earlier CPAP treatment
Physical and mental disability that compromises the normal use of CPAP
CPAP intolerance
Current use of sedative (benzodiazepine and non-benzodiazepine GABA-esgic agonist) or antidepressant medication for a time period inferior to 3 weeks.
Female patient who is pregnant, lactating or has a positive pregnancy test result.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
An Mariman, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
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Nasal Continuous Positive Airway Pressure (CPAP) in Chronic Fatigue and Sleep-disordered Breathing
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