Investigating the Sleeping Habits of Patients With Haemop... | NCT04795921

Studies
Investigating the Sleeping Habits of Patients With Haemophilia

NCT04795921

Sponsor

University Hospital, Bonn

Status

Unknown status

Last Update Posted

Oct 21, 2021Actual

Enrollment

208Estimated

Phase

Not provided

Conditions

Sleep Disorder
Psychological
Activity, Motor

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Mar 31, 2022Estimated

Completion Date

Mar 31, 2022Estimated

First Submitted Date

Mar 9, 2021

First Submission Date that Met QC Criteria

Mar 9, 2021

First Posted Date

Mar 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2021

Last Update Posted Date

Oct 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

PD Dr. Andreas Strauß, specialist for orthopaedics and trauma surgery, University Hospital, BonnPrincipal Investigator

Lead Sponsor

University Hospital, BonnOTHER

Collaborators

Name	Class
University of Wuppertal	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

208Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleeping habits	Questionnaire on sleeping habits (SF/BR B)	15 Minutes

Secondary Outcomes

Measure	Description	Time Frame
Physical activity	Questionnaire on physical activity level (self-developed Questionnaire)	10 Minutes
Psychological distress	Health survey of psychological distress (PHQ9)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andreas Strauss, MD	Contact	004922828714176		andreas.strauss@ukbonn.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Bonn	Recruiting	Bonn	Northrhine Westfalia	53127	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

The publication of anonymous patient data is not allowed by informed consent.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012893	Sleep Wake Disorders
D009043	Motor Activity

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided