Anxiety StateMEM-ASANCT04368416
Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
An observational study of Anxiety State and Sleep Disturbance, run by University Hospital, Caen at 1 site in France.
Trial summary
The goal of MEM-ASA is to investigate the prevalence of anxiety/depression, sleep disturbances and alcohol use disorder in elderly with cognitive complaints. In memory clinics of Normandy (France), all patients aged over 50 year-old are systematically questioned about anxiety, depression, sleep quality and alcohol use… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Anxiety State, Sleep Disturbance, Alcohol Abuse
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2020to 31 Dec 2024
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of memory clinics in Normandy.
Who may be able to join
- To have cognitive complaints
- To have french as native language
- Not to be opposed to be included
- To be affiliated to the social security
Who cannot join
- -To be under tutorship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Caen, 14000
Pierre BRANGER, MD, 33231065548, branger-p@chu-caen.fr
About this study
Official title: Prevalence of Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
The goal of MEM-ASA is to investigate the prevalence of anxiety/depression, sleep disturbances and alcohol use disorder in elderly with cognitive complaints.
In memory clinics of Normandy (France), all patients aged over 50 year-old are systematically questioned about anxiety, depression, sleep quality and alcohol use disorder. They also perform a neuropsychological assessment. Questionnaires are given to the patient and his/her caregiver to be filled in at home.
Levels of anxiety/depression, sleep quality and alcohol consumption are related to neuropsychological performance, diagnosis and responses to the questionaires.
- Conditions
- Anxiety State, Sleep Disturbance, Alcohol Abuse, Aging, Dementia
- Medical subject headings
- Anxiety Disorders, Parasomnias, Alcoholism, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and depression
Responses to questions during anamnesis
Measured: At inclusion
Sleep quality
Responses to questions during anamnesis
Measured: At inclusion
Alcohol use disorder
Responses to questions during anamnesis
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start22 Sep 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre BRANGER, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368416
- Sponsor's protocol ID
- 2019-A02928-49
- Acronym
- MEM-ASA
- Status last verified
- Feb 2023
- First submitted
- 27 Apr 2020
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
- ClinicalTrials.gov ID
- NCT04368416
- Acronym / sponsor ID
- MEM-ASA / 2019-A02928-49
- Conditions
- Anxiety State, Sleep Disturbance, Alcohol Abuse, Aging, Dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Apr 2020 (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.
The goal of MEM-ASA is to investigate the prevalence of anxiety/depression, sleep disturbances and alcohol use disorder in elderly with cognitive complaints.
In memory clinics of Normandy (France), all patients aged over 50 year-old are systematically questioned about anxiety, depression, sleep quality and alcohol use disorder. They also perform a neuropsychological assessment. Questionnaires are given to the patient and his/her caregiver to be filled in at home.
Levels of anxiety/depression, sleep quality and alcohol consumption are related to neuropsychological performance, diagnosis and responses to the questionaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of memory clinics in Normandy.
Key inclusion criteria (4 listed)
- To have cognitive complaints
- To have french as native language
- Not to be opposed to be included
- To be affiliated to the social security
Key exclusion criteria (1 listed)
- -To be under tutorship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anxiety and depression
Time frame: At inclusion
Responses to questions during anamnesis
Sleep quality
Time frame: At inclusion
Responses to questions during anamnesis
Alcohol use disorder
Time frame: At inclusion
Responses to questions during anamnesis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Anxiety State
Not yet recruiting
The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
Episiotomy, Pain
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Not yet recruiting
Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section
Anxiety, Cesarean Section
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
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 BRANGER, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety State and Sleep Disturbance, run by University Hospital, Caen 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre BRANGER, MD (33231065548, branger-p@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and depression (time frame: At inclusion). The study lists 3 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 13 Feb 2024.