Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT01368718
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01368718
Study Brief:
Protocol Section:
NCT01368718