Clinical trial NCT01368718: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Fatigue With OSA
Chronic Fatigue Syndrome With OSA
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2011-06-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: baseline evaluation.
timeFrame: At day 0
measure: Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: first treatment + effect evaluation.
timeFrame: Treatment takes 28 days after first evaluation
measure: Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: second treatment + effect evaluation.
timeFrame: Treatment takes 28 days after second evaluation
Secondary outcomes:
measure: The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: baseline evaluation.
timeFrame: At day 0
measure: The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: first treatment + effect evaluation.
timeFrame: Treatment takes 28 days after first evaluation
measure: The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: second treatment + effect evaluation.
timeFrame: Treatment takes 28 days after second evaluation
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: An Mariman, MD
role: PRINCIPAL_INVESTIGATOR
References: