Sleep ApnoeaMiClASNCT02615431

The Influence of MitraClip on Apnoea Asleep

An observational study of Sleep Apnoea, run by RWTH Aachen University at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

The aim of the present study is to influence the central and obstructive sleep apnoea in patients with severe mitral insufficiency by an interventional MitraClip examination to evaluate. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sleep Apnoea
What is being tested?: MitraClip Intervention
How many people: 34 participants
Where: 1 siteGermany
Study dates: Nov 2015to Nov 2016
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: male and female patients is planned an interventional MitraClip examination

Who may be able to join

patient suffer on severe symptomatical mitral insufficience
male and female patients is planned an interventional MitraClip examination
Dyspnea with a NYHA (New York Heart Association) II - III
an high logistic Euro-Score (> 20)
no execution of surgical intervention because of relevant comorbidities

Who cannot join

younger than 18 years
pregnancy and breast-feeding
persons without mental ability of capacity to understand and follow the instructions of the investigator
persons in dependence from the sponsor or working with the sponsor
participation in other studies

Trial locations and contacts

1 site in 1 country.

Germany1 site

University Hospital RWTH Aachen, Department of Medical Clinic I
Aachen

Other trials in Germany

About this study

Official title: the Influence of MitraClip on Apnoea Asleep

The aim of the present study is to influence the central and obstructive sleep apnoea in patients with severe mitral insufficiency by an interventional MitraClip examination to evaluate.

Conditions: Sleep Apnoea
Being tested: MitraClip Intervention
Medical subject headings: Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MitraClip InterventionOther

Study groups in NCT02615431
Study group	Role	What they receive
MitraClip Intervention		the influence of MitraClip on Apnoea Asleep Receives: Other: MitraClip Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Apnoea-Hypopnoea-Index
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Nov 2016

First posted26 Nov 2015 (estimated)
Study startNov 2015
Primary completionNov 2016 (estimated)
Study completionNov 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sleep ApnoeaStudies 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: 34 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02615431
Sponsor's protocol ID: 15-060
Acronym: MiClAS
Status last verified: Nov 2015
First submitted: 19 Nov 2015
Last updated: 10 Jun 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

All Sleep Apnoea trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: the Influence of MitraClip on Apnoea Asleep
ClinicalTrials.gov ID: NCT02615431
Acronym / sponsor ID: MiClAS / 15-060
Conditions: Sleep Apnoea
Study type: Observational
Recruitment status: Unknown status
Enrolment: 34 participants (estimated)
Lead sponsor: RWTH Aachen UniversityUniversity, hospital or other
Study start: Nov 2015
Primary completion: Nov 2016 (estimated)
Study completion: Nov 2016 (estimated)
First posted: 26 Nov 2015 (estimated)
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.

The aim of the present study is to influence the central and obstructive sleep apnoea in patients with severe mitral insufficiency by an interventional MitraClip examination to evaluate.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
MitraClip Intervention	–	Other: MitraClip Interventionthe influence of MitraClip on Apnoea Asleep

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: male and female patients is planned an interventional MitraClip examination

Key inclusion criteria (5 listed)

patient suffer on severe symptomatical mitral insufficience
male and female patients is planned an interventional MitraClip examination
Dyspnea with a NYHA (New York Heart Association) II - III
an high logistic Euro-Score (> 20)
no execution of surgical intervention because of relevant comorbidities

Key exclusion criteria (5 listed)

younger than 18 years
pregnancy and breast-feeding
persons without mental ability of capacity to understand and follow the instructions of the investigator
persons in dependence from the sponsor or working with the sponsor
participation in other studies

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MitraClip Intervention	Other	MitraClip Intervention

Primary outcome

Apnoea-Hypopnoea-Index
Time frame: 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.

Related trials for Sleep Apnoea

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

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.

Michael Dreher, MD principal investigator

Uniklinik RWTH Aachen, Med. Klinik I

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 Apnoea, run by RWTH Aachen University 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 5 inclusion and 5 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 10 Jun 2016. 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?

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?

Apnoea-Hypopnoea-Index (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02615431.

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 10 Jun 2016.