Investigating the Sleeping Habits of Patients With Haemophilia

NCT04795921 | Unknown

• 1 other identifier: HaemSleep20210208
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder; Psychological; Activity, Motor

Outcome Measures

Primary Outcomes (1)

• Sleeping habits

  Questionnaire on sleeping habits (SF/BR B)

  15 Minutes

Secondary Outcomes (5)

• Physical activity

  10 Minutes

• Psychological distress

  10 Minutes

• Kinesiophobia

  5 Minutes

• Subjective pain perception

  5 Minutes

• Adherence to prophylactic treatment

  5 Minutes

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study aims to include 104 patients with haemophilia as well as 104 age-matched healthy controls.

You may qualify if:

• adult (≥ 18 years) patients with haemophilia (all severities) or Von-Willebrand-Disease (Typ III)
• female carriers
• signed informed consent

You may not qualify if:

• patients with other bleeding disorders
• patients with acute injuries, psychological disorders or Prior surgeries (in the last 6 weeks)
• no signed informed consent

Sponsors & Collaborators

• University Hospital, Bonn: lead
• University of Wuppertal: collaborator

Study Sites (1)

University Hospital of Bonn

Bonn, Northrhine Westfalia, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Central Study Contacts

Andreas Strauss, MD

CONTACT

004922828714176; andreas.strauss@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist for orthopaedics and trauma surgery

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: June 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: October 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)