Hereditary Hemorrhagic Telangiectasia (HHT)NCT07886632
Prevalence of Obstructive Sleep Apnea in HHT and HHT-specific Challenges in OSA-therapy - a Retrospective Cohort Study
An observational study of Hereditary Hemorrhagic Telangiectasia (HHT) and Obstructive Sleep Apnea (OSA), run by University Hospital, Essen.
Trial summary
Hereditary hemorrhagic telangiectasia (HHT) is an autosomal dominant vascular disorder (prevalence approx. 1:5,000-1:8,000) characterized by recurrent epistaxis, mucocutaneous telangiectasias and visceral vascular malformations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Hemorrhagic Telangiectasia (HHT), Obstructive Sleep Apnea (OSA)
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: the entirety of patients presenting at our center with confirmed HHT diagnosis between 2014 and 2026 above 18 years
Who may be able to join
- confirmed HHT for group HHT without OSA, confirmed HHT and documented OSA for group HHT with OSA
Who cannot join
None listed.
About this study
Official title: Prävalenz Der Obstruktiven Schlafapnoe (OSA) Bei Hereditärer Hämorrhagischer Teleangiektasie (HHT) Und HHT-spezifische Herausforderungen Der OSA-Therapie - Eine Retrospektive Kohortenanalyse
Hereditary hemorrhagic telangiectasia (HHT) is an autosomal dominant vascular disorder (prevalence approx. 1:5,000-1:8,000) characterized by recurrent epistaxis, mucocutaneous telangiectasias and visceral vascular malformations. Chronic bleeding frequently leads to anemia and iron deficiency, which is associated with restless legs syndrome. Our earlier work suggested that up to 22% of affected patients may suffer from it. Nocturnal epistaxis, nasal clots, and nasal obstruction may further disturb sleep, and positive airway pressure (PAP) therapy may dry out the nasal mucosa, aggravate bleeding, and cause mask intolerance. The association between obstructive sleep apnea (OSA) and HHT has not yet been adequately studied.
This retrospective, exploratory, hypothesis-generating analysis aims to determine the frequency of OSA diagnoses documented in the clinical records of our existing HHT cohort. The primary endpoint is this documented frequency, explicitly interpreted as a minimum frequency rather than a true prevalence, since not all patients were systematically screened. Secondary endpoints include details of OSA diagnostics and treatment course, complications of OSA therapy in HHT patients, OSA-related comorbidities (e.g., arterial hypertension, obesity), medication and potential adverse effects (especially respiratory depression), hypoxia-related laboratory parameters (iron status, anemia), and general patient and disease characteristics (sex, weight, height, Curaçao criteria). The findings are intended to inform a possible subsequent prospective screening phase.
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic, Sleep Apnea, Obstructive
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 |
|---|---|---|
| HHT group without OSA | HHT patients without OSA | |
| HHT with OSA | HHT patients with OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
obstructive sleep apnea
Measured: up to 12 years from first included patients, end of 2026 the latest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Hemorrhagic Telangiectasia (HHT)Studies 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carolin Schleupner, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886632
- Sponsor's protocol ID
- 26-13316-BO
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prävalenz Der Obstruktiven Schlafapnoe (OSA) Bei Hereditärer Hämorrhagischer Teleangiektasie (HHT) Und HHT-spezifische Herausforderungen Der OSA-Therapie - Eine Retrospektive Kohortenanalyse
- ClinicalTrials.gov ID
- NCT07886632
- Acronym / sponsor ID
- 26-13316-BO
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Oct 2026 (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.
Hereditary hemorrhagic telangiectasia (HHT) is an autosomal dominant vascular disorder (prevalence approx. 1:5,000-1:8,000) characterized by recurrent epistaxis, mucocutaneous telangiectasias and visceral vascular malformations. Chronic bleeding frequently leads to anemia and iron deficiency, which is associated with restless legs syndrome. Our earlier work suggested that up to 22% of affected patients may suffer from it. Nocturnal epistaxis, nasal clots, and nasal obstruction may further disturb sleep, and positive airway pressure (PAP) therapy may dry out the nasal mucosa, aggravate bleeding, and cause mask intolerance. The association between obstructive sleep apnea (OSA) and HHT has not yet been adequately studied.
This retrospective, exploratory, hypothesis-generating analysis aims to determine the frequency of OSA diagnoses documented in the clinical records of our existing HHT cohort. The primary endpoint is this documented frequency, explicitly interpreted as a minimum frequency rather than a true prevalence, since not all patients were systematically screened. Secondary endpoints include details of OSA diagnostics and treatment course, complications of OSA therapy in HHT patients, OSA-related comorbidities (e.g., arterial hypertension, obesity), medication and potential adverse effects (especially respiratory depression), hypoxia-related laboratory parameters (iron status, anemia), and general patient and disease characteristics (sex, weight, height, Curaçao criteria). The findings are intended to inform a possible subsequent prospective screening phase.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HHT group without OSA | – | –HHT patients without OSA |
| HHT with OSA | – | –HHT patients with OSA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the entirety of patients presenting at our center with confirmed HHT diagnosis between 2014 and 2026 above 18 years
Key inclusion criteria (1 listed)
- confirmed HHT for group HHT without OSA, confirmed HHT and documented OSA for group HHT with OSA
Key exclusion criteria (0 listed)
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
obstructive sleep apnea
Time frame: up to 12 years from first included patients, end of 2026 the latest
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Hemorrhagic Telangiectasia (HHT) and Obstructive Sleep Apnea (OSA), run by University Hospital, Essen.
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 1 inclusion and 0 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
obstructive sleep apnea (time frame: up to 12 years from first included patients, end of 2026 the latest). 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 2026.