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Clinical Trials/NCT06659575
NCT06659575
Completed
Not Applicable

Prevalence of Sleep Disturbances in Elderly People Hospitalized in Medicine, Psychiatry and Rehabilitation Departments: TOPASE Prospective Study, RIPH 3

University Hospital, Angers10 sites in 1 country104 target enrollmentJanuary 20, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
D012893
Sponsor
University Hospital, Angers
Enrollment
104
Locations
10
Primary Endpoint
The difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale.
Status
Completed
Last Updated
8 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 20, 2025
End Date
January 26, 2025
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Angers
Responsible Party
Sponsor

Eligibility Criteria

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,
  • Anticipated hospital stay \> 48 hours

Exclusion 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 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.

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • 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(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).(3 days)

Study Sites (10)

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