Investigating the Sleeping Habits of Patients With Haemophilia

Sponsor
University Hospital, Bonn (Other)
Overall Status
Recruiting
CT.gov ID
NCT04795921
Collaborator
University of Wuppertal (Other)
208
1
10
20.9

Study Details

Study Description

Brief Summary

This investigation aims to explore sleeping habits in patients with haemophilia.

These patients often suffer from joint pain, which leads to restricted physical activity. Further, many of the patients suffer from psychological strains, such as depression. Both depression and restricted physical activity can result in sleeping disorders. Thus it is aimed to find out which factors and comorbidities do play a role within sleeping habits in patients with haemophilia.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    208 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Investigating the Sleeping Habits of Patients With Haemophilia
    Actual Study Start Date :
    Jun 1, 2021
    Anticipated Primary Completion Date :
    Mar 31, 2022
    Anticipated Study Completion Date :
    Mar 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with haemophilia

    This investigation includes patients with haemophilia of all seventies (mild, moderate, severe), as well as female carriers and patients with Von-Willebrand-Disease (Typ III)

    Healthy controls

    The control group consists of adult healthy female and male subjects.

    Outcome Measures

    Primary Outcome Measures

    1. Sleeping habits [15 Minutes]

      Questionnaire on sleeping habits (SF/BR B)

    Secondary Outcome Measures

    1. Physical activity [10 Minutes]

      Questionnaire on physical activity level (self-developed Questionnaire)

    2. Psychological distress [10 Minutes]

      Health survey of psychological distress (PHQ9)

    3. Kinesiophobia [5 Minutes]

      Tampa Scale of Kinesiophobia (scale 1-5)

    4. Subjective pain perception [5 Minutes]

      Questionnaire on Pain Sensitivity

    5. Adherence to prophylactic treatment [5 Minutes]

      Questionnaire on adherence to prophylactic Treatment (VERITAS-Pro)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • adult (≥ 18 years) patients with haemophilia (all severities) or Von-Willebrand-Disease (Typ III)

    • female carriers

    • signed informed consent

    Exclusion Criteria:
    • patients with other bleeding disorders

    • patients with acute injuries, psychological disorders or Prior surgeries (in the last 6 weeks)

    • no signed informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Bonn Bonn Northrhine Westfalia Germany 53127

    Sponsors and Collaborators

    • University Hospital, Bonn
    • University of Wuppertal

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PD Dr. Andreas Strauß, specialist for orthopaedics and trauma surgery, University Hospital, Bonn
    ClinicalTrials.gov Identifier:
    NCT04795921
    Other Study ID Numbers:
    • HaemSleep20210208
    First Posted:
    Mar 12, 2021
    Last Update Posted:
    Oct 21, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 21, 2021