Prevalence of Sleep Disturbances in Elderly People Hospitalized in Medicine, Psychiatry and Rehabilitation Departments: TOPASE Prospective Study, RIPH 3
- Conditions
- D012893Sleep Disorder
- Registration Number
- NCT06659575
- Lead Sponsor
- University Hospital, Angers
- Brief 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.
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale. 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)
- Secondary Outcome Measures
Name Time Method Participants numbers repartitions within departments categories following their spiegel score 3 days * There is three categories: conventional medicine, psychiatry or medical care and rehabilitation.
* Spiegel score ranks from 0 to 30 (Questionnaire)Distributions of the number of participants within hospital facility types following their Spiegel score 3 days * Four hospital categories: university hospitals, city hospitals, specialized hospitals and community hospitasl.
* Spiegel score ranks from 0 to 30Distribution of the number of participants in the different room types according to their Spiegel score 3 days * Three different room types: Single or double without roomate and full double room
* Spiegel score ranks from 0 to 30Distributions of the number of participants by age group following Spiegel score 3 days * Three age categories: 60-74 years, 75-89 years, 90 years and above
* Spiegel score ranks from 0 to 30Distribution of number of participants by gender and Spiegel score 3 days * Gender
* Spiegel score ranks from 0 to 30Distribution of the number of patients within a list of different reported causes of sleep disorders (Questionnaire). 3 days 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 : ________________________________________________
Trial Locations
- Locations (10)
Angers_CHU
🇫🇷Angers, France
Etablissement de santé Baugeois-Vallée
🇫🇷Beaufort-en-Anjou, France
CH de la corniche angevine
🇫🇷Chalonnes-sur-Loire, France
Cholet_Ch
🇫🇷Cholet, France
CH Doué-en-Anjou
🇫🇷Doué-en-Anjou, France
CH intercommunal Lys-Hyrôme
🇫🇷Lys-Haut-Layon, France
Césame
🇫🇷Sainte Gemmes-sur-Loire, France
CH Longué-Jumelles
🇫🇷Saumur, France
Saumur_Ch
🇫🇷Saumur, France
CH Layon-Aubance
🇫🇷Terranjou, France