Investigating the Sleeping Habits of Patients With Haemophilia

Sleep Disorder Clinical Trial

Official title:

Investigating the Sleeping Habits of Patients With Haemophilia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04795921
• Other study ID #: HaemSleep20210208
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2021
• Source: University Hospital, Bonn
• Contact: Andreas Strauss, MD
• Phone: 004922828714176
• Email: andreas.strauss[@]ukbonn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Activity, Motor
• Psychological
• Sleep Disorder
• Sleep Wake Disorders

Locations

Country	Name	City	State
Germany	University Hospital of Bonn	Bonn	Northrhine Westfalia

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bonn	University of Wuppertal

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleeping habits	Questionnaire on sleeping habits (SF/BR B)	15 Minutes
Secondary	Physical activity	Questionnaire on physical activity level (self-developed Questionnaire)	10 Minutes
Secondary	Psychological distress	Health survey of psychological distress (PHQ9)	10 Minutes
Secondary	Kinesiophobia	Tampa Scale of Kinesiophobia (scale 1-5)	5 Minutes
Secondary	Subjective pain perception	Questionnaire on Pain Sensitivity	5 Minutes
Secondary	Adherence to prophylactic treatment	Questionnaire on adherence to prophylactic Treatment (VERITAS-Pro)	5 Minutes