Sleep Apnea SyndromesNCT02969551
Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE
An observational study of Sleep Apnea Syndromes, run by Technical University of Munich at 1 site in Germany.
Trial summary
Patients with OSA receive manometry measurements with Apneagraph (AG) during one night of sleep. All patients are simultaneously evaluated with polysomnography. Patients who are not eligible for CPAP therapy are additionally studied with drug-induced sleep endoscopy (DISE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Manometry and possibly DISE
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Mar 2017
- 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: Patient with a diagnosed obstructive sleep apnea Syndrome.
Who may be able to join
- Apnea-Hypopnea-Index (AHI) ≥ 5.
Who cannot join
- age <18 years;
- body mass index (BMI) of >35 kg/m2; active infection;
- previous oral, head, or neck surgery in the last 3 months; pregnancy; chronic use of alcohol (> 60g ethanol per day or > 150g ethanol per week) or sedatives; illicit drug use;
- chronic obstructive pulmonary disease.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Hals- Nasen- Ohrenheilkunde
München, Bavaria, 81675
Clemens Heiser, MD, +49 89 41409583, hno@heiser-online.com
About this study
Patients with OSA receive manometry measurements with Apneagraph (AG) during one night of sleep. All patients are simultaneously evaluated with polysomnography. Patients who are not eligible for CPAP therapy are additionally studied with drug-induced sleep endoscopy (DISE). The frequency and obstructions patterns in different sleep stages are assessed. In addition obstruction patterns detected with AG are compared with DISE examination in the selected cases.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Manometry and possibly DISE
- 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.
Manometry and possibly DISEDevice
A Manometry is performed on all patients. After it in some Patient DISE is followed
| Study group | Role | What they receive |
|---|---|---|
| Sleep apnea, Manometry and possibly DISE | Sleep apnea Patients recieved manometry measures and those who were not considered for CPAP Therapy recieved Drug induced sleep endoscopy. Receives: Device: Manometry and possibly DISE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of obstruction depending of sleep stage
Measured: 8
Secondary outcomes (1)
Comparing the manometry findings to DISE
Measured: 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clemens Heiser, MD, Study chair, attending doctor in ENT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969551
- Sponsor's protocol ID
- 88/14
- Status last verified
- Mar 2017
- First submitted
- 17 Nov 2016
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE
- ClinicalTrials.gov ID
- NCT02969551
- Acronym / sponsor ID
- 88/14
- Conditions
- Sleep Apnea Syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (estimated)
- First posted
- 21 Nov 2016 (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.
Patients with OSA receive manometry measurements with Apneagraph (AG) during one night of sleep. All patients are simultaneously evaluated with polysomnography. Patients who are not eligible for CPAP therapy are additionally studied with drug-induced sleep endoscopy (DISE). The frequency and obstructions patterns in different sleep stages are assessed. In addition obstruction patterns detected with AG are compared with DISE examination in the selected cases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep apnea, Manometry and possibly DISE | – | Device: Manometry and possibly DISESleep apnea Patients recieved manometry measures and those who were not considered for CPAP Therapy recieved Drug induced sleep endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a diagnosed obstructive sleep apnea Syndrome.
Key inclusion criteria (1 listed)
- Apnea-Hypopnea-Index (AHI) ≥ 5.
Key exclusion criteria (4 listed)
- age <18 years;
- body mass index (BMI) of >35 kg/m2; active infection;
- previous oral, head, or neck surgery in the last 3 months; pregnancy; chronic use of alcohol (> 60g ethanol per day or > 150g ethanol per week) or sedatives; illicit drug use;
- chronic obstructive pulmonary disease.
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 |
|---|---|---|
| Manometry and possibly DISEA Manometry is performed on all patients. After it in some Patient DISE is followed | Device | Sleep apnea, Manometry and possibly DISE |
Primary outcome
Detection of obstruction depending of sleep stage
Time frame: 8
1 secondary outcome
Comparing the manometry findings to DISE
Time frame: 1 Hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- 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. This study is not recruiting at the moment.
Clemens Heiser, MD study chair
attending doctor in ENT
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 Apnea Syndromes, run by Technical University of Munich 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 1 inclusion and 4 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 20 Mar 2017. 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 Clemens Heiser, MD (+49 8941409583, hno@heiser-online.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of obstruction depending of sleep stage (time frame: 8). 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 20 Mar 2017.