Sleep DisorderNCT04795921
Investigating the Sleeping Habits of Patients With Haemophilia
An observational study of Sleep Disorder and Psychological, run by University Hospital, Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorder, Psychological, Activity, Motor
- How many people
- 208 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study aims to include 104 patients with haemophilia as well as 104 age-matched healthy controls.
Who may be able to join
- adult (≥ 18 years) patients with haemophilia (all severities) or Von-Willebrand-Disease (Typ III)
- female carriers
- signed informed consent
Who cannot join
- patients with other bleeding disorders
- patients with acute injuries, psychological disorders or Prior surgeries (in the last 6 weeks)
- no signed informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Bonn
Bonn, Northrhine Westfalia, 53127
Andreas Strauß, PD Dr.
Andreas Strauß, PD Dr.
About this study
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
- Medical subject headings
- Sleep Wake Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleeping habits
Questionnaire on sleeping habits (SF/BR B)
Measured: 15 Minutes
Secondary outcomes (5)
Physical activity
Questionnaire on physical activity level (self-developed Questionnaire)
Measured: 10 Minutes
Psychological distress
Health survey of psychological distress (PHQ9)
Measured: 10 Minutes
Kinesiophobia
Tampa Scale of Kinesiophobia (scale 1-5)
Measured: 5 Minutes
Subjective pain perception
Questionnaire on Pain Sensitivity
Measured: 5 Minutes
Adherence to prophylactic treatment
Questionnaire on adherence to prophylactic Treatment (VERITAS-Pro)
Measured: 5 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Jun 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wuppertal
- Responsible party
- Principal investigator, PD Dr. Andreas Strauß, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795921
- Sponsor's protocol ID
- HaemSleep20210208
- Status last verified
- Jun 2021
- First submitted
- 9 Mar 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The publication of anonymous patient data is not allowed by informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Sleeping Habits of Patients With Haemophilia
- ClinicalTrials.gov ID
- NCT04795921
- Acronym / sponsor ID
- HaemSleep20210208
- Conditions
- Sleep Disorder, Psychological, Activity, Motor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- University of Wuppertal
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study aims to include 104 patients with haemophilia as well as 104 age-matched healthy controls.
Key inclusion criteria (3 listed)
- adult (≥ 18 years) patients with haemophilia (all severities) or Von-Willebrand-Disease (Typ III)
- female carriers
- signed informed consent
Key exclusion criteria (3 listed)
- patients with other bleeding disorders
- patients with acute injuries, psychological disorders or Prior surgeries (in the last 6 weeks)
- no signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleeping habits
Time frame: 15 Minutes
Questionnaire on sleeping habits (SF/BR B)
5 secondary outcomes
Physical activity
Time frame: 10 Minutes
Psychological distress
Time frame: 10 Minutes
Kinesiophobia
Time frame: 5 Minutes
Subjective pain perception
Time frame: 5 Minutes
Adherence to prophylactic treatment
Time frame: 5 Minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: No. The publication of anonymous patient data is not allowed by informed consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder and Psychological, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Strauss, MD (004922828714176, andreas.strauss@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleeping habits (time frame: 15 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.