ClinicalTrials.Veeva

Menu

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

U

University Hospital, Angers

Status

Completed

Conditions

Sleep Disorder
D012893

Study type

Observational

Funder types

Other

Identifiers

NCT06659575
49RC24_0305
2024-A01996-41 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

104 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

104 participants in 1 patient group

Patients aged 60 and over hospitalized, expected length of stay > 48 hours
Description:
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.

Trial contacts and locations

10

Loading...

Central trial contact

Aurélie LAFEUILLE, Nurse

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems