BIOLOGICAL CLOCKSSOMVIENCT00804804
Aging, Sleep, Cognitive Process
A study testing Sleep deprivation and multiple rest in people with BIOLOGICAL CLOCKS, run by University Hospital, Bordeaux at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- BIOLOGICAL CLOCKS
- What is being tested?
- Sleep deprivation and multiple rest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesFrance
- Study dates
- Dec 2008to Feb 2011
- Phase
- Interventional
- 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 20 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- absence of periodic movement disorder (MPS<15)
- regular sleep schedule during 3 days before study participation
- affiliated to the french health care system
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
France3 sites
Genpphass
Bordeaux, 33076
Uh Purpan
Toulouse, 31300
Medes-Imps
Toulouse, 31405
About this study
Official title: Aging,Sleep and Cognitive Process
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
Read the detailed description
Social evolutions (nocturnal activity, shift work) have consequently reduced average sleep duration average. In addition, aging leads to a physiological reduction of nocturnal sleep duration.
Many studies have shown that extended wakefulness impairs nocturnal performances measured with a simple reaction time test (SRTT) and that this decrement is also age-related. In deed, young subjects (20-30 years) are more affected than old subjects (50-60 years) during an extended wakefulness period.
The results obtained in confinement constant conditions, associated to a high or low sleep pressure, show that this difference observed between young and old subjects should be essentially related to a reduced circadian regulation (ex : reduced melatonin secretion) with age rather than to a reduced sleep pressure (homeostatic regulation) as previously suggested. However, studies on confinement have shown that sleep pressure (identified during the sleep period with the EEG delta band) could be reduced with aging specifically on the anterior brain regions (frontal regions).
It is well-known that executive performances (related to frontal lobes functioning) are affected by extended wakefulness, but respective effects of age, circadian system and sleep pressure in this decrement remain unknown.
The aim of this study is to determine the evolution of the executive functions during a 40-hour extended wakefulness period ("high sleep pressure protocol") or during a multiple nap protocol ("low sleep pressure protocol") according to the subjects' age, in constant experimental conditions of confinement.
It's a repeated measurements study with protocol (sleep deprivation and multiple naps) and time of day as within factors and age group (young versus older subjects) as between factor
- Conditions
- BIOLOGICAL CLOCKS
- Being tested
- Sleep deprivation and multiple rest
- Keywords
- Sleep, aging, cognitives processes, constant routine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep deprivation and multiple restOther
To determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement
Sleep deprivation and multiple restOther
To determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement
Sleep deprivation and multiple restOther
To determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement
Sleep deprivation and multiple restOther
To determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement
| Study group | Role | What they receive |
|---|---|---|
| Y1 | Experimental | young volunteers (20-30 years), morningness chronotype Receives: Other: Sleep deprivation and multiple rest |
| Y2 | Experimental | young volunteers (20-30 years), eveningness chronotype Receives: Other: Sleep deprivation and multiple rest |
| O1 | Experimental | Aged volunteers (65-75 years), morningness chronotype Receives: Other: Sleep deprivation and multiple rest |
| O 2 | Experimental | aged volunteers (65-75 years), eveningness chronotype Receives: Other: Sleep deprivation and multiple rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: every 3h45
Secondary outcomes (1)
Nocturnal sleep quality before and after 2 constant conditions measured by PSG Sleep pressure quantified by Karolinska test and EEG delta band Subjective sleepiness and fatigue evaluated by Karolinska sleepiness scale and visual analogue scale
Measured: every 3h45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BIOLOGICAL CLOCKSStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre PHILIP, MD,PHD, Principal investigator, University Hospital Bordeaux France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804804
- Sponsor's protocol ID
- CHUBX 2008/17
- Other IDs
- 2008-A00869-46
- Acronym
- SOMVIE
- Status last verified
- Mar 2011
- First submitted
- 8 Dec 2008
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging,Sleep and Cognitive Process
- ClinicalTrials.gov ID
- NCT00804804
- Acronym / sponsor ID
- SOMVIE / CHUBX 2008/17
- Conditions
- BIOLOGICAL CLOCKS
- Keywords
- Sleep, aging, cognitives processes, constant routine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 9 Dec 2008 (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.
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
Detailed description
Social evolutions (nocturnal activity, shift work) have consequently reduced average sleep duration average. In addition, aging leads to a physiological reduction of nocturnal sleep duration.
Many studies have shown that extended wakefulness impairs nocturnal performances measured with a simple reaction time test (SRTT) and that this decrement is also age-related. In deed, young subjects (20-30 years) are more affected than old subjects (50-60 years) during an extended wakefulness period.
The results obtained in confinement constant conditions, associated to a high or low sleep pressure, show that this difference observed between young and old subjects should be essentially related to a reduced circadian regulation (ex : reduced melatonin secretion) with age rather than to a reduced sleep pressure (homeostatic regulation) as previously suggested. However, studies on confinement have shown that sleep pressure (identified during the sleep period with the EEG delta band) could be reduced with aging specifically on the anterior brain regions (frontal regions).
It is well-known that executive performances (related to frontal lobes functioning) are affected by extended wakefulness, but respective effects of age, circadian system and sleep pressure in this decrement remain unknown.
The aim of this study is to determine the evolution of the executive functions during a 40-hour extended wakefulness period ("high sleep pressure protocol") or during a multiple nap protocol ("low sleep pressure protocol") according to the subjects' age, in constant experimental conditions of confinement.
It's a repeated measurements study with protocol (sleep deprivation and multiple naps) and time of day as within factors and age group (young versus older subjects) as between factor
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Y1 | Experimental | Other: Sleep deprivation and multiple restyoung volunteers (20-30 years), morningness chronotype |
| Y2 | Experimental | Other: Sleep deprivation and multiple restyoung volunteers (20-30 years), eveningness chronotype |
| O1 | Experimental | Other: Sleep deprivation and multiple restAged volunteers (65-75 years), morningness chronotype |
| O 2 | Experimental | Other: Sleep deprivation and multiple restaged volunteers (65-75 years), eveningness chronotype |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| Sleep deprivation and multiple restTo determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement | Other | Y1 |
| Sleep deprivation and multiple restTo determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement | Other | Y2 |
| Sleep deprivation and multiple restTo determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement | Other | O1 |
| Sleep deprivation and multiple restTo determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement | Other | O 2 |
Primary outcome
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
Time frame: every 3h45
1 secondary outcome
Nocturnal sleep quality before and after 2 constant conditions measured by PSG Sleep pressure quantified by Karolinska test and EEG delta band Subjective sleepiness and fatigue evaluated by Karolinska sleepiness scale and visual analogue scale
Time frame: every 3h45
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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.
Pierre PHILIP, MD,PHD principal investigator
University Hospital Bordeaux France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep deprivation and multiple rest in people with BIOLOGICAL CLOCKS, run by University Hospital, Bordeaux at 3 sites in France.
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 9 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 (time frame: every 3h45). 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 1 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.