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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01996-41 | Other Identifier | ANSM |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients aged 60 and over hospitalized, expected length of stay > 48 hours | Inclusion criteria
Non-inclusion criteria
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
NB: - Spiegel score ranks from 0 to 30 (Questionnaire) | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Participants numbers repartitions within departments categories following their spiegel score |
| 3 days |
| Distributions of the number of participants within hospital facility types following their Spiegel score |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers_CHU | Angers | 49933 | France | |||
| Etablissement de santé Baugeois-Vallée |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 29, 2026 | |
| Reset | Jun 24, 2026 |
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|
| 3 days |
| Distribution of the number of participants in the different room types according to their Spiegel score |
| 3 days |
| Distributions of the number of participants by age group following Spiegel score |
| 3 days |
| Distribution of number of participants by gender and Spiegel score |
| 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 :
| 3 days |
| Baugé-en-Anjou |
| 49250 |
| France |
| CH de la corniche angevine | Chalonnes-sur-Loire | 49290 | France |
| Cholet_Ch | Cholet | 49300 | France |
| CH intercommunal Lys-Hyrôme | Cholet | 49310 | France |
| Césame | Sainte-Gemmes-sur-Loire | 49130 | France |
| CH Longué-Jumelles | Saumur | 49400 | France |
| Saumur_Ch | Saumur | 49400 | France |
| CH Doué-en-Anjou | Saumur | 49700 | France |
| CH Layon-Aubance | Thouarcé | 49540 | France |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 29, 2026 | Jun 24, 2026 |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D006970 | Disorders of Excessive Somnolence |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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