Sleep ArchitectureSCOALNCT01650454
Sleep, Cognition and Memory Disorder
A study testing 2 night polysomnography, battery of neuropsychological tests and virtual reality test in people with Sleep Architecture and Sleep Disorders, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The increasing incidence of Alzheimer's disease (AD) and related sleep-disorders with the aging of the population is a major issue of public health. The prevalence of sleep disturbances is about 50% in dementia patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Architecture, Sleep Disorders, Cognitive Impairment
- What is being tested?
- 2 night polysomnography, battery of neuropsychological tests and virtual reality test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to 29 Oct 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Being under guardian conservator
- Residence in skilled nursing facility
- Pregnant or breast feeding woman
- Alzheimer's disease caused by gene mutations
- Having a neurological disease
- History of stroke within the past three months
Show all 9Show fewer
- Generalized anxiety (DSM-IV criteria)
- Schizophrenia history (DSM-IV criteria)
- Illiteracy, is unable to count or to read
Trial locations and contacts
1 site in 1 country.
About this study
The increasing incidence of Alzheimer's disease (AD) and related sleep-disorders with the aging of the population is a major issue of public health. The prevalence of sleep disturbances is about 50% in dementia patients. Sleep in dementia is mainly characterized by prolonged night-time awakenings, sometimes with longer sleep latency and/or early awakening. The presence of these sleep disturbances is the main reason for the institutionalization of AD patients, as well as a major cause of the deterioration of the caregivers' sleep. The MEMENTO cohort is composed of patients with isolated memory complaints or mild cognitive impairment, at high risk to develop dementia. All voluntary patients from the CMRR (Center of Memory, resources and Research) of Bordeaux (MEMENTO cohort) will be tested at inclusion and followed-up 1 year later. For these two evaluations, actigraphic monitoring at home, 2-night polysomnography (PSG) monitoring at hospital including a 24-hour period of urinary melatonin dosage, neuropsychological tests battery, a virtual reality tool and questionnaires will be used.
- Conditions
- Sleep Architecture, Sleep Disorders, Cognitive Impairment
- Being tested
- 2 night polysomnography, battery of neuropsychological tests, virtual reality test, subjective evaluation of sleep and somnolence
- Keywords
- Alzheimer, Sleep, Somnolence
- Medical subject headings
- Sleep Wake Disorders, Cognitive Dysfunction, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 night polysomnographyOther
Polysomnography
battery of neuropsychological testsOther
virtual reality testOther
subjective evaluation of sleep and somnolenceOther
| Study group | Role | What they receive |
|---|---|---|
| Patients from Memento cohort. | Experimental | Patients with mild cognitive impairment included in MEMENTO cohort.
These patients will have a 2 night polysomnography, a battery of neuropsychological tests, a virtual reality test, and a subjective evaluation of sleep and somnolence at inclusion (Month 0) and Month 12. Receives: Other: 2 night polysomnography; Other: battery of neuropsychological tests; Other: virtual reality test; Other: subjective evaluation of sleep and somnolence |
| Patients with memory disorders | Experimental | Patients with mild cognitive impairment not included in MEMENTO cohort. For these patients a virtual reality test, and a subjective evaluation of sleep and somnolence will be performed at Inclusion (Month 0) Receives: Other: virtual reality test; Other: subjective evaluation of sleep and somnolence |
| Healthy volunteers | Active comparator | Healthy volunteers matched in age, sex and educational level with patients. For these volunteers a virtual reality test, and a subjective evaluation of sleep and somnolence will be performed at Inclusion (Month 0) Receives: Other: virtual reality test; Other: subjective evaluation of sleep and somnolence |
| control group | Active comparator | this group is composed with Healthy volunteers these volunteers will have a 2 night polysomnography, a battery of neuropsychological tests, a virtual reality test, and a subjective evaluation of sleep and somnolence at inclusion (Month 0) and Month 12. Receives: Other: 2 night polysomnography; Other: battery of neuropsychological tests; Other: virtual reality test; Other: subjective evaluation of sleep and somnolence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography of night 1
- Apnea/Hypopnea index, periodic limb movements index
Measured: Change from inclusion (Month 0) and Month 12
Polysomnography of night 1
- Excessive transient muscle activity, Sustained muscle activity
Measured: Change from inclusion (Month 0) and Month 12
Polysomnography of night 1
- Sleep structure parameters (% stage 1, 2, 3 and Rapid Eye movement, Delta activity, Spindle rate)
Measured: Change from inclusion (Month 0) and Month 12
Polysomnography of night 1
- Sleep duration parameters
Measured: Change from inclusion (Month 0) and Month 12
Polysomnography of night 1
- Sleep consolidation parameters
Measured: Change from inclusion (Month 0) and Month 12
Polysomnography of night 1
- Sleep propensity parameters 24-hour melatonin quantity rate
Measured: Change from inclusion (Month 0) and Month 12
Polysomnography of night 1
Actimetry: Inter-daily stability, intra-daily variability, rhythm amplitude
Measured: Change from inclusion (Month 0) and Month 12
Secondary outcomes (3)
Subjective evaluation of sleep and Somnolence
Measured: Month 0 and Month 12
Evaluation of Memory disorder
Reaction times and % of errors in the neuropsychological tests (memory, speed processing, language, visuo-spatial skills, attentional functions, executive functions)
Measured: Month 0 and Month12
Evaluation of Memory disorder
% of recall from the memory test in a virtual environment
Measured: Month 0 and Month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJan 2013
- Primary completion29 Oct 2015
- Study completion29 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ArchitectureStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Philip, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650454
- Sponsor's protocol ID
- CHUBX 2012/02
- Acronym
- SCOAL
- Status last verified
- Jun 2021
- First submitted
- 18 Jul 2012
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Cognition and Memory Disorder
- ClinicalTrials.gov ID
- NCT01650454
- Acronym / sponsor ID
- SCOAL / CHUBX 2012/02
- Conditions
- Sleep Architecture, Sleep Disorders, Cognitive Impairment
- Keywords
- Alzheimer, Sleep, Somnolence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- 29 Oct 2015 (actual)
- Study completion
- 29 Oct 2015 (actual)
- First posted
- 26 Jul 2012 (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 increasing incidence of Alzheimer's disease (AD) and related sleep-disorders with the aging of the population is a major issue of public health. The prevalence of sleep disturbances is about 50% in dementia patients. Sleep in dementia is mainly characterized by prolonged night-time awakenings, sometimes with longer sleep latency and/or early awakening. The presence of these sleep disturbances is the main reason for the institutionalization of AD patients, as well as a major cause of the deterioration of the caregivers' sleep. The MEMENTO cohort is composed of patients with isolated memory complaints or mild cognitive impairment, at high risk to develop dementia. All voluntary patients from the CMRR (Center of Memory, resources and Research) of Bordeaux (MEMENTO cohort) will be tested at inclusion and followed-up 1 year later. For these two evaluations, actigraphic monitoring at home, 2-night polysomnography (PSG) monitoring at hospital including a 24-hour period of urinary melatonin dosage, neuropsychological tests battery, a virtual reality tool and questionnaires will be used.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients from Memento cohort. | Experimental | Other: 2 night polysomnography, Other: battery of neuropsychological tests, Other: virtual reality test, Other: subjective evaluation of sleep and somnolencePatients with mild cognitive impairment included in MEMENTO cohort. These patients will have a 2 night polysomnography, a battery of neuropsychological tests, a virtual reality test, and a subjective evaluation of sleep and somnolence at inclusion (Month 0) and Month 12. |
| Patients with memory disorders | Experimental | Other: virtual reality test, Other: subjective evaluation of sleep and somnolencePatients with mild cognitive impairment not included in MEMENTO cohort. For these patients a virtual reality test, and a subjective evaluation of sleep and somnolence will be performed at Inclusion (Month 0) |
| Healthy volunteers | Active comparator | Other: virtual reality test, Other: subjective evaluation of sleep and somnolenceHealthy volunteers matched in age, sex and educational level with patients. For these volunteers a virtual reality test, and a subjective evaluation of sleep and somnolence will be performed at Inclusion (Month 0) |
| control group | Active comparator | Other: 2 night polysomnography, Other: battery of neuropsychological tests, Other: virtual reality test, Other: subjective evaluation of sleep and somnolencethis group is composed with Healthy volunteers these volunteers will have a 2 night polysomnography, a battery of neuropsychological tests, a virtual reality test, and a subjective evaluation of sleep and somnolence at inclusion (Month 0) and Month 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Being under guardian conservator
- Residence in skilled nursing facility
- Pregnant or breast feeding woman
- Alzheimer's disease caused by gene mutations
- Having a neurological disease
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 |
|---|---|---|
| 2 night polysomnographyPolysomnography | Other | Patients from Memento cohort., control group |
| battery of neuropsychological tests | Other | Patients from Memento cohort., control group |
| virtual reality test | Other | Healthy volunteers, Patients from Memento cohort., Patients with memory disorders, control group |
| subjective evaluation of sleep and somnolence | Other | Healthy volunteers, Patients from Memento cohort., Patients with memory disorders, control group |
Primary outcome
Polysomnography of night 1
Time frame: Change from inclusion (Month 0) and Month 12
- Apnea/Hypopnea index, periodic limb movements index
Polysomnography of night 1
Time frame: Change from inclusion (Month 0) and Month 12
- Excessive transient muscle activity, Sustained muscle activity
Polysomnography of night 1
Time frame: Change from inclusion (Month 0) and Month 12
- Sleep structure parameters (% stage 1, 2, 3 and Rapid Eye movement, Delta activity, Spindle rate)
Polysomnography of night 1
Time frame: Change from inclusion (Month 0) and Month 12
- Sleep duration parameters
Polysomnography of night 1
Time frame: Change from inclusion (Month 0) and Month 12
- Sleep consolidation parameters
Polysomnography of night 1
Time frame: Change from inclusion (Month 0) and Month 12
- Sleep propensity parameters 24-hour melatonin quantity rate
Polysomnography of night 1
Time frame: Change from inclusion (Month 0) and Month 12
Actimetry: Inter-daily stability, intra-daily variability, rhythm amplitude
3 secondary outcomes
Subjective evaluation of sleep and Somnolence
Time frame: Month 0 and Month 12
Evaluation of Memory disorder
Time frame: Month 0 and Month12
Evaluation of Memory disorder
Time frame: Month 0 and Month12
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 Jul 2021.
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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, Pr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 night polysomnography, battery of neuropsychological tests and virtual reality test in people with Sleep Architecture and Sleep Disorders, run by University Hospital, Bordeaux at 1 site 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 0 inclusion and 9 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 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Polysomnography of night 1 (time frame: Change from inclusion (Month 0) and Month 12). The study lists 7 primary outcomes in all. 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 Jul 2021.