CompletedNot Applicable

Aging, Sleep, Cognitive Process

France28 participantsStarted 2008-12

Plain-language summary

The aim of the study is to determine the impact of aging, circadian rhythms and sleep deprivation on executive performances. Volunteers will complete a 40-hour extended wakefulness period in constant condition (semi-recumbent posture in bed, constant dim light levels \< 10 lux, food and liquid intake at regular intervals) in order to control the circadian system. The volunteers will not be allowed to sleep in the sleep deprivation protocol ("high sleep pressure protocol") and will adopt a short wakefulness/sleep cycle (150/75 minutes) in the multiple nap protocol ("low sleep pressure protocol"). Tests and scales will be repeated every 3H45

Who can participate

Age range

20 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Executive functions will be evaluated by a Go/NoGo task and a Stop Signal. Performances will be measured with a visual simple reaction time task

Timeframe: every 3h45

Trial details

NCT IDNCT00804804

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-02

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