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Completed

NCT Number: NCT06659575

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

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

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Key information

Conditions

D012893 Disorders of Excessive Somnolence Dyssomnias Fatigue Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers_CHU, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Participants numbers repartitions within departments categories following their spiegel score

    Time frame: 3 days

    • There is three categories: conventional medicine, psychiatry or medical care and rehabilitation.
    • Spiegel score ranks from 0 to 30 (Questionnaire)

  2. Distributions of the number of participants within hospital facility types following their Spiegel score

    Time frame: 3 days

    • Four hospital categories: university hospitals, city hospitals, specialized hospitals and community hospitasl.
    • Spiegel score ranks from 0 to 30

  3. Distribution of the number of participants in the different room types according to their Spiegel score

    Time frame: 3 days

    • Three different room types: Single or double without roomate and full double room
    • Spiegel score ranks from 0 to 30

  4. Distributions of the number of participants by age group following Spiegel score

    Time frame: 3 days

    • Three age categories: 60-74 years, 75-89 years, 90 years and above
    • Spiegel score ranks from 0 to 30

  5. Distribution of number of participants by gender and Spiegel score

    Time frame: 3 days

    • Gender
    • Spiegel score ranks from 0 to 30

  6. Distribution of the number of patients within a list of different reported causes of sleep disorders (Questionnaire).

    Time frame: 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 : ________________________________________________

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: TOPASE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2024
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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