Sleep DisorderMEMOWAVENCT04875442
Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions
A study testing Memowave emitting sounds and Memowave not emitting sounds in people with Sleep Disorder, run by BioSerenity at 1 site in France.
Trial summary
Safety and performance study of the MemoWave electroencephalographic and sound recording device to increase slow brain waves during sleep to improve memory consolidation in subjects with mild cognitive impairment Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Memowave emitting sounds and Memowave not emitting sounds
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2023to 30 Dec 2026
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject presenting a mild cognitive disorder of the amnesic type, defined by a memory complaint, a Mini Mental State ≥ 24 and a score ≤26 on free recall or ≤45 / 48 on total recall) of the RLRI16 episodic verbal memory test
- At least 7 years of schooling
Who cannot join
- Severe psychiatric pathology
- Known neurological pathology
- High risk of apnea syndrome defined by at least 2 positive categories (each with a score ≥2) on the Berlin Questionnaire for Apnea Syndrome Screening
- High risk of behavioral disorder in REM sleep defined by an RBDSQ score> 5.
- Taking sleeping pills or antidepressants
- Severe heart disease or unbalanced diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions MemoWave Aimed at Increasing Slow Brain Waves During Sleep to Improve Memory Consolidation in Subjects With Mild Cognitive Impairment
Safety and performance study of the MemoWave electroencephalographic and sound recording device to increase slow brain waves during sleep to improve memory consolidation in subjects with mild cognitive impairment
Read the detailed description
24 subjects aged between 40 and 85 years, presenting a mild cognitive disorder of the amnesic type (ie a memory complaint, a Mini Mental State ≥ 24 and a score ≤26 on free recall or ≤45 / 48 on total recall of the RLRI16 test) will be included;
Each patient spends 3 polysomnography nights at hospital: 1 night of habituation without Memowave device and next 2 nights with Memovave.
The device emits sounds to increase slow brain waves but Memowave emits sounds during only one of the two nights of test (night placebo vs night "verum"). The attribution of the night is randomized.
- Conditions
- Sleep Disorder
- Being tested
- Memowave emitting sounds, Memowave not emitting sounds
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memowave emitting soundsDevice
Memowave is worn during one night and emits sounds to increase slow brain waves
Memowave not emitting soundsDevice
Memowave is worn during one night and doesn't emit sounds
| Study group | Role | What they receive |
|---|---|---|
| Memowave emitting sound | Experimental | Patients worn Memowave during one night, and the device emits sounds to increase slow brain signals Receives: Device: Memowave emitting sounds |
| Memowave not emitting sound | Placebo comparator | Patients worn Memowave during one night, and the device doesn't emit sounds Receives: Device: Memowave not emitting sounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of Electroencephalography signals of Memowave
number of slow waves of Memomave divided by number of slow waves of Gold standard should be under 1
Measured: 3 days
Secondary outcomes (3)
Quality of the sleep
Score of 1 to 4 (where 4 is a good sleep and 1 a very bad sleep)
Measured: 3 days
efficiency on mnesic consolidation
memory grid .More the score is high, more the efficiency is better
Measured: 3 days
efficiency on mnesic consolidation
scale WAIS (Weschler Adult Intelligence scale). The score should be more than 100.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start30 Oct 2023 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: PROJECT STOPPED
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The device studied is worn during the 2 polysomnogaphy nights. The device emits sounds during only one night in order to observe the difference of EEG signals. The night during which the device emits sounds is determined by randomization. The nature of the second night with the device, will be the reverse of the first, in a crossover fashion.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioSerenity
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875442
- Sponsor's protocol ID
- 2020-A01806-33
- Acronym
- MEMOWAVE
- Status last verified
- Oct 2023
- First submitted
- 10 Dec 2020
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions MemoWave Aimed at Increasing Slow Brain Waves During Sleep to Improve Memory Consolidation in Subjects With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04875442
- Acronym / sponsor ID
- MEMOWAVE / 2020-A01806-33
- Conditions
- Sleep Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PROJECT STOPPED
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioSerenityIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 May 2021 (actual)
- 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.
Safety and performance study of the MemoWave electroencephalographic and sound recording device to increase slow brain waves during sleep to improve memory consolidation in subjects with mild cognitive impairment
Detailed description
24 subjects aged between 40 and 85 years, presenting a mild cognitive disorder of the amnesic type (ie a memory complaint, a Mini Mental State ≥ 24 and a score ≤26 on free recall or ≤45 / 48 on total recall of the RLRI16 test) will be included;
Each patient spends 3 polysomnography nights at hospital: 1 night of habituation without Memowave device and next 2 nights with Memovave.
The device emits sounds to increase slow brain waves but Memowave emits sounds during only one of the two nights of test (night placebo vs night "verum"). The attribution of the night is randomized.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The device studied is worn during the 2 polysomnogaphy nights. The device emits sounds during only one night in order to observe the difference of EEG signals. The night during which the device emits sounds is determined by randomization. The nature of the second night with the device, will be the reverse of the first, in a crossover fashion.
| Arm | Type | Receives |
|---|---|---|
| Memowave emitting sound | Experimental | Device: Memowave emitting soundsPatients worn Memowave during one night, and the device emits sounds to increase slow brain signals |
| Memowave not emitting sound | Placebo comparator | Device: Memowave not emitting soundsPatients worn Memowave during one night, and the device doesn't emit sounds |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject presenting a mild cognitive disorder of the amnesic type, defined by a memory complaint, a Mini Mental State ≥ 24 and a score ≤26 on free recall or ≤45 / 48 on total recall) of the RLRI16 episodic verbal memory test
- At least 7 years of schooling
Key exclusion criteria (6 listed)
- Severe psychiatric pathology
- Known neurological pathology
- High risk of apnea syndrome defined by at least 2 positive categories (each with a score ≥2) on the Berlin Questionnaire for Apnea Syndrome Screening
- High risk of behavioral disorder in REM sleep defined by an RBDSQ score> 5.
- Taking sleeping pills or antidepressants
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 |
|---|---|---|
| Memowave emitting soundsMemowave is worn during one night and emits sounds to increase slow brain waves | Device | Memowave emitting sound |
| Memowave not emitting soundsMemowave is worn during one night and doesn't emit sounds | Device | Memowave not emitting sound |
Primary outcome
accuracy of Electroencephalography signals of Memowave
Time frame: 3 days
number of slow waves of Memomave divided by number of slow waves of Gold standard should be under 1
3 secondary outcomes
Quality of the sleep
Time frame: 3 days
efficiency on mnesic consolidation
Time frame: 3 days
efficiency on mnesic consolidation
Time frame: 3 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memowave emitting sounds and Memowave not emitting sounds in people with Sleep Disorder, run by BioSerenity 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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 24 Oct 2023. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
accuracy of Electroencephalography signals of Memowave (time frame: 3 days). 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 24 Oct 2023.