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:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT00804804
Eligibility Criteria:
Inclusion Criteria:
* excessive daytime sleepiness (Epworth Sleepiness Scale score \> 9),
* sleep complaint such as sleep apnea or insomnia (Basic Nordic Sleep Questionnaire, items score \< 4 except questions 3, 4 and 15a for aged volunteers),
* not intermediate in terms of morningness and eveningness according to the Horne-Ostberg questionnaire for young volunteers
* absence of psychopathology evidenced during psychologist interview or on the Symptom Check List (SCL-90R score\>59)
* sleep efficiency evidenced by actimetry (\>85%) during 7 days
* absence of apnea/hypopnea syndrome (RDI\<15)
* absence of periodic movement disorder (MPS\<15)
* regular sleep schedule during 3 days before study participation
* affiliated to the french health care system
Exclusion Criteria:
* volunteers with sleep disorders or organic disorders affecting sleep,
* poor sleep hygiene or abnormal usual sleep patterns,
* night workers or shift-workers,
* substance abusers (caffeine, drug, or alcohol).
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT00804804
Study Brief:
Protocol Section:
NCT00804804