Chronic Fatigue With OSAPhase 4NCT01368718
Nasal Continuous Positive Airway Pressure (CPAP) in Chronic Fatigue and Sleep-disordered Breathing
A Phase 4 study of Chronic Fatigue With OSA and Chronic Fatigue Syndrome With OSA, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Fatigue With OSA, Chronic Fatigue Syndrome With OSA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2012to 11 Apr 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nasal CPAP in Patients With Chronic Fatigue and Sleep-disordered Breathing
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.
- Being tested
- Active CPAP is compared with sham CPAP as a control intervention.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active CPAP is compared with sham CPAP as a control intervention.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Active/Sham CPAP | Other | Not described Receives: Procedure: Active CPAP is compared with sham CPAP as a control intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At day 0
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.
Measured: Treatment takes 28 days after first evaluation
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.
Measured: Treatment takes 28 days after second evaluation
Secondary outcomes (3)
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.
Measured: At day 0
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.
Measured: Treatment takes 28 days after first evaluation
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.
Measured: Treatment takes 28 days after second evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startOct 2012
- Primary completionDec 2015
- Study completion11 Apr 2017
Why it stopped: low inclusion and adherence rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue With OSAStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- An Mariman, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368718
- Sponsor's protocol ID
- 2011/191
- Status last verified
- Dec 2022
- First submitted
- 6 Jun 2011
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nasal CPAP in Patients With Chronic Fatigue and Sleep-disordered Breathing
- ClinicalTrials.gov ID
- NCT01368718
- Acronym / sponsor ID
- 2011/191
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low inclusion and adherence rates
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active/Sham CPAP | Other | Procedure: Active CPAP is compared with sham CPAP as a control intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active CPAP is compared with sham CPAP as a control intervention.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. | Procedure or surgery | Active/Sham CPAP |
Primary outcome
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: baseline evaluation.
Time frame: At day 0
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.
Time frame: Treatment takes 28 days after first 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.
Time frame: Treatment takes 28 days after second 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.
3 secondary outcomes
The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: baseline evaluation.
Time frame: At day 0
The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: first treatment + effect evaluation.
Time frame: Treatment takes 28 days after first evaluation
The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: second treatment + effect evaluation.
Time frame: Treatment takes 28 days after second evaluation
Results and safety
The study was stopped early (reason given: low inclusion and adherence rates). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
An Mariman, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Chronic Fatigue With OSA and Chronic Fatigue Syndrome With OSA, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low inclusion and adherence rates). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: baseline evaluation. (time frame: At day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.