D012893TOPASENCT06659575
Prevalence of Sleep Disturbances in Elderly People Hospitalized in Medicine, Psychiatry and Rehabilitation Departments: TOPASE Prospective Study, RIPH 3
An observational study of D012893 and Sleep Disorder, run by University Hospital, Angers at 10 sites in France.
Trial summary
Objectives and evaluation criteria: The main objective of this study is to evaluate changes in sleep quality in patients aged 60 and over since their admission to a medical, psychiatric or medical and rehabilitation ward in one of the GHT 49 healthcare establishments. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- D012893, Sleep Disorder
- How many people
- 104 participants
- Where
- 10 sitesFrance
- Study dates
- 20 Jan 2025to 26 Jan 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As the study is essentially descriptive, aimed at taking stock of the situation, the calculation of the number of patients to be included was not based on a hypothesis test. Pragmatically, the investigator plan to include the maximum number of patients meeting the criteria during the targeted week. Given the number of beds in the GHT 49 establishments in the departments concerned, and the average number of new admissions, the investigator estimate that 200 patients could be included.
Who may be able to join
- Patients aged 60 and over hospitalized in a conventional medicine, psychiatry or medical and rehabilitation department of one of the GHT 49 healthcare establishments,
- Anticipated hospital stay > 48 hours
Who cannot join
- Patient hospitalized for more than 24 hours,
- Inability to answer a questionnaire (assessment by the investigator or the medical team in charge of the patient (dementia, etc.),
- No mastery of French
- Patient hospitalized for sleep pathology (evaluation or treatment),
- Patient hospitalized in an intensive psychiatric care room,
- Patients hospitalized under duress,
- Patient opposition,
- Patient under guardianship or curatorship.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Angers_CHU
Angers, 49933
Etablissement de santé Baugeois-Vallée
Baugé-en-Anjou, 49250
CH de la corniche angevine
Chalonnes-sur-Loire, 49290
Cholet_Ch
Cholet, 49300
CH intercommunal Lys-Hyrôme
Cholet, 49310
Césame
Sainte-Gemmes-sur-Loire, 49130
CH Longué-Jumelles
Saumur, 49400
Saumur_Ch
Saumur, 49400
CH Doué-en-Anjou
Saumur, 49700
CH Layon-Aubance
Thouarcé, 49540
About this study
Objectives and evaluation criteria:
The main objective of this study is to evaluate changes in sleep quality in patients aged 60 and over since their admission to a medical, psychiatric or medical and rehabilitation ward in one of the GHT 49 healthcare establishments.
Read more
The primary endpoint will be the difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale.
Research plan and procedure:
Patients participating in the study will be asked to complete a questionnaire including the Spiegel scale at two points during their hospitalization:
- Day 0: questionnaire n°1 to assess sleep quality on the night prior to hospitalization, including the Spiegel scale.
- Day 2 (morning of the third day of hospitalization): during the morning, depending on the organization of the ward, questionnaire n°2 to assess sleep quality during the previous night, including the Spiegel scale.
Number of research participants:
As the study is essentially descriptive, aimed at taking stock of the situation, the calculation of the number of patients to be included was not based on a hypothesis test.
Pragmatically, the investigator plan to include the maximum number of patients meeting the criteria during the targeted week.
Given the number of beds in the GHT 49 establishments in the departments concerned, and the average number of new admissions, the investigator estimate that 200 patients could be included.
Research duration:
Inclusion period: 5 days, Monday to Friday Participation period: 3 days (from day 0 to day 2) Study duration: 7 days
- Conditions
- D012893, Sleep Disorder
- Keywords
- Sleep Wake Disorders, Sleep, elderly, hospitalized, recovery process, rehospitalizations, overmedication, iatrogenics, daytime sleepiness, fatigue
- Medical subject headings
- Sleep Wake Disorders, Disorders of Excessive Somnolence, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients aged 60 and over hospitalized, expected length of stay > 48 hours | Inclusion criteria * Patients aged 60 and over hospitalized in a conventional medicine, psychiatry or medical and rehabilitation department of one of the GHT 49 healthcare establishments, * expected length of stay > 48 hours. Non-inclusion criteria * Patient hospitalized for more than 24 hours, * Inability to answer a questionnaire (assessment by the investigator or the medical team in charge of the patient (dementia, etc.), * No command of French, * Patient hospitalized for sleep pathology (evaluation or treatment), * Patient hospitalized in an intensive psychiatric care room, * Patients hospitalized under duress, * Patient opposition, * Patient under guardianship or curatorship. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale.
The main objective of this study is to evaluate changes in sleep quality in patients aged 60 and over since their admission to a medical, psychiatric or medical and rehabilitation ward in one of the GHT 49 healthcare establishments.
The primary endpoint will be the difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale.
Patients participating in the study will be asked to complete a questionnaire including the Spiegel scale at two points during their hospitalization:
- Day 0: questionnaire n°1 to assess sleep quality on the night prior to hospitalization, including the Spiegel scale.
- Day 2 (morning of the third day of hospitalization): during the morning, depending on the organization of the ward, questionnaire n°2 to assess sleep quality during the previous night, including the Spiegel scale.
NB: - Spiegel score ranks from 0 to 30 (Questionnaire)
Measured: 3 days
Secondary outcomes (6)
Participants numbers repartitions within departments categories following their spiegel score
- There is three categories: conventional medicine, psychiatry or medical care and rehabilitation.
- Spiegel score ranks from 0 to 30 (Questionnaire)
Measured: 3 days
Distributions of the number of participants within hospital facility types following their Spiegel score
- Four hospital categories: university hospitals, city hospitals, specialized hospitals and community hospitasl.
- Spiegel score ranks from 0 to 30
Measured: 3 days
Distribution of the number of participants in the different room types according to their Spiegel score
- Three different room types: Single or double without roomate and full double room
- Spiegel score ranks from 0 to 30
Measured: 3 days
Distributions of the number of participants by age group following Spiegel score
- Three age categories: 60-74 years, 75-89 years, 90 years and above
- Spiegel score ranks from 0 to 30
Measured: 3 days
Distribution of number of participants by gender and Spiegel score
- Gender
- Spiegel score ranks from 0 to 30
Measured: 3 days
Distribution of the number of patients within a list of different reported causes of sleep disorders (Questionnaire).
Was your sleep disturbed last night? 0 No 1 Yes
If yes :
- Anxiety
- Need to go to the toilet
- Noise
- Change in rhythm of life (mealtimes, bedtimes, toilet times, etc.)
- Medical devices (e.g. infusion, urinary catheter, dressing, etc.)
- Pain
- Light
- My illness (clinical signs)
- Lack of physical activity during the day
- Smell
- Visits from carers
- Taking medication to sleep / absence / modification of usual treatment
- Quality of bedding
- Feeling hungry or thirsty
- Room temperature
- Room neighbor
- Other : ________________________________________________
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 posted26 Oct 2024
- Study start20 Jan 2025
- Primary completion26 Jan 2025
- Study completion26 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D012893Studies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659575
- Sponsor's protocol ID
- 49RC24_0305
- Other IDs
- 2024-A01996-41
- Acronym
- TOPASE
- Status last verified
- Aug 2025
- First submitted
- 14 Oct 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sleep Disturbances in Elderly People Hospitalized in Medicine, Psychiatry and Rehabilitation Departments: TOPASE Prospective Study, RIPH 3
- ClinicalTrials.gov ID
- NCT06659575
- Acronym / sponsor ID
- TOPASE / 49RC24_0305
- Conditions
- D012893, Sleep Disorder
- Keywords
- Sleep Wake Disorders, Sleep, elderly, hospitalized, recovery process, rehospitalizations, overmedication, iatrogenics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 26 Jan 2025 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 26 Oct 2024 (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.
Objectives and evaluation criteria:
The main objective of this study is to evaluate changes in sleep quality in patients aged 60 and over since their admission to a medical, psychiatric or medical and rehabilitation ward in one of the GHT 49 healthcare establishments.
The primary endpoint will be the difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale.
Research plan and procedure:
Patients participating in the study will be asked to complete a questionnaire including the Spiegel scale at two points during their hospitalization:
- Day 0: questionnaire n°1 to assess sleep quality on the night prior to hospitalization, including the Spiegel scale.
- Day 2 (morning of the third day of hospitalization): during the morning, depending on the organization of the ward, questionnaire n°2 to assess sleep quality during the previous night, including the Spiegel scale.
Number of research participants:
As the study is essentially descriptive, aimed at taking stock of the situation, the calculation of the number of patients to be included was not based on a hypothesis test.
Pragmatically, the investigator plan to include the maximum number of patients meeting the criteria during the targeted week.
Given the number of beds in the GHT 49 establishments in the departments concerned, and the average number of new admissions, the investigator estimate that 200 patients could be included.
Research duration:
Inclusion period: 5 days, Monday to Friday Participation period: 3 days (from day 0 to day 2) Study duration: 7 days
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged 60 and over hospitalized, expected length of stay > 48 hours | – | –Inclusion criteria * Patients aged 60 and over hospitalized in a conventional medicine, psychiatry or medical and rehabilitation department of one of the GHT 49 healthcare establishments, * expected length of stay > 48 hours. Non-inclusion criteria * Patient hospitalized for more than 24 hours, * Inability to answer a questionnaire (assessment by the investigator or the medical team in charge of the patient (dementia, etc.), * No command of French, * Patient hospitalized for sleep pathology (evaluation or treatment), * Patient hospitalized in an intensive psychiatric care room, * Patients hospitalized under duress, * Patient opposition, * Patient under guardianship or curatorship. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As the study is essentially descriptive, aimed at taking stock of the situation, the calculation of the number of patients to be included was not based on a hypothesis test. Pragmatically, the investigator plan to include the maximum number of patients meeting the criteria during the targeted week. Given the number of beds in the GHT 49 establishments in the departments concerned, and the average number of new admissions, the investigator estimate that 200 patients could be included.
Key inclusion criteria (2 listed)
- Patients aged 60 and over hospitalized in a conventional medicine, psychiatry or medical and rehabilitation department of one of the GHT 49 healthcare establishments,
- Anticipated hospital stay > 48 hours
Key exclusion criteria (8 listed)
- Patient hospitalized for more than 24 hours,
- Inability to answer a questionnaire (assessment by the investigator or the medical team in charge of the patient (dementia, etc.),
- No mastery of French
- Patient hospitalized for sleep pathology (evaluation or treatment),
- Patient hospitalized in an intensive psychiatric care room,
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
The difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale.
Time frame: 3 days
The main objective of this study is to evaluate changes in sleep quality in patients aged 60 and over since their admission to a medical, psychiatric or medical and rehabilitation ward in one of the GHT 49 healthcare establishments. The primary endpoint will be the difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale. Patients participating in the study will be asked to complete a questionnaire including the Spiegel scale at two points during their hospitalization: * Day 0: questionnaire n°1 to assess sleep quality on the night prior to hospitalization, including the Spiegel scale. * Day 2 (morning of the third day of hospitalization): during the morning, depending on the organization of the ward, questionnaire n°2 to assess sleep quality during the previous night, including the Spiegel scale. NB: - Spiegel score ranks from 0 to 30 (Questionnaire)
6 secondary outcomes
Participants numbers repartitions within departments categories following their spiegel score
Time frame: 3 days
Distributions of the number of participants within hospital facility types following their Spiegel score
Time frame: 3 days
Distribution of the number of participants in the different room types according to their Spiegel score
Time frame: 3 days
Distributions of the number of participants by age group following Spiegel score
Time frame: 3 days
Distribution of number of participants by gender and Spiegel score
Time frame: 3 days
Distribution of the number of patients within a list of different reported causes of sleep disorders (Questionnaire).
Time frame: 3 days
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 28 Aug 2025.
- Individual participant dataSharing planned: Undecided
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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of D012893 and Sleep Disorder, run by University Hospital, Angers at 10 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 2 inclusion and 8 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 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
The difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale. (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 28 Aug 2025.