Obstructive Sleep ApneaPATT-OSANCT03924817
Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstructive Sleep Apnea - PATT-OSA Registry
An observational study of Obstructive Sleep Apnea, run by ResMed at 4 sites in Germany.
Trial summary
During sleep, the muscle tonus in the oropharyngeal space is lost, the tongue might fall back andthe volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 500 participants
- Where
- 4 sitesGermany
- Study dates
- 1 Feb 2024to 31 Dec 2026
- How long will I take part?
- 3 Months
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible for recruitment are male and female patients of ≥ 18 years who have been diagnosed with OSA and who are not eligible for PAP treatment (no tolerance of PAP therapy, therapy refusal for any reason). Patients who have been prescribed an MAD as treatment for OSA. Patients will be followed in their clinical routine treatment pathway.
Who may be able to join
- Prescription of any mandibular advancement device
- Age ≥ 18 years
- Ability to understand the study information and information on usage of personal data
- Signed and dated informed consent
Who cannot join
- Patients with central sleep apnea (central AI > 5/hour)
- Patients with loose teeth and severe parodontitis
- Patients with completely missing teeth or removable tooth replacement, or with a teeth health insufficient to retain an MAD Patients with missing molars Patients with maximum protrusion of less than 5mm
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Zentrum für Schlafmedizin Dr. Warmuth
Berlin, State of Berlin, 12683
Schlaf- und Beatmungszentrum Blaubeuren
Blaubeuren Abbey, Badden-Württemberg, 89143
Ruhrlandklinik Essen
Essen, North Rhine-Westphalia, 45239
Universitätsklinikum Regensburg - Klinik für Innere Medizin II
Regensburg, 93053
About this study
During sleep, the muscle tonus in the oropharyngeal space is lost, the tongue might fall back andthe volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. The person asleep might compensate the flow limitation by breathing faster, which causes the soft tissue to vibrate (= snoring). Further narrowing of the airways can lead to obstructive apneas (complete airway collapse and stopping of airflow). First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Since PAP involves wearing a facial mask that applies air pressure into the airways, some patients cannot tolerate this therapy. These patients might be candidates for an alternative treatment approach with a mandibular advancement device (MAD).
Read the detailed description
During sleep, the muscles in the oropharyngeal space relax, the tongue falls back and the volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. Diminishing airflow can lead to snoring or to the airways collapsing completely (obstructive sleep apnea, OSA). Patients who suffer from OSA have trouble breathing during sleep and will have a disturbed sleep architecture as repeated airway closure causes wake reactions and arousals. This does not only lead to severe daytime sleepiness with high risk of causing car accidents, for instance, but also affects synaptic activity during sleep and the balance of blood gas levels. These factors can have a aggravating effect on blood pressure and worsen the prognosis for cardiovascular comorbidities. First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Positive airway pressure is being applied through a facial mask and some patients cannot tolerate this therapy or refuse it. An alternative treatment approach is by fitting an MAD that the patient wears during sleep. An MAD pushes the lower jar forward and thereby increases the volume of the upper airways, thus preventing them to close. Studies have shown good compliance with MAD therapy and benefits in terms of sleepiness and quality of life. The Narval registry study aims to investigate MAD usage in real life and reasons for non-compliance. The registry aims to record patient characteristics (e.g. comorbidities) and side effects that lead to a termination of therapy, but also how the costs for therapy are split between the patient and public or private health insurance providers and how this affects therapy initiation and usage.
- Conditions
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the Apnoea-Hypopnea-Index (AHI) at baseline compared to a follow-up after 3 months
Changes in the number of apnoeas (cessation of airflow) and hypopneas (reduced airflow) at baseline and at follow-up
Measured: 3 months
Secondary outcomes (10)
Changes in sleep-related quality of life from baseline compared to 3 months follow-up
Changes in sleep-related quality of life assessed with the questionnaire FOSQ (Functional Outcomes of Sleep Questionnaire). The Functional Outcomes of Sleep questionnaire is a "self-report measure designed to assess the impact of disorders of excessive sleepiness on multiple activities of daily living" (Weaver 1997). It consists of 10 questions categorized as General Productivity, Social Outcome, Activity Level, Vigilance, Sexual Activity. The range of scores for any item is 1-4. The potential range of scores for the total score is 5-20, with 5 meaning bad sleep-related quality of life and 20 good sleep-related quality of life. The total score is being calculated by calculating the mean of the subscale scores and then multiply that mean by five. Missing or not applicable answers will not be added when calculating the mean subscale scores.
Measured: 3 months
Changes in daytime sleepiness from baseline compared to 3 months follow-up
Changes in daytime sleepiness assessed with the Epworth Sleepiness Scale questionnaire (ESS, measures the likelihood of a patient of falling asleep during daytime as self-reported outcome). The ESS is self-reported measure to assess whether a person would be prone to fall asleep in typical daily situations. It consists of 8 questions that can be answered with 0 = would never fall asleep, 1 = slight probability of falling asleep, 2 = moderate probability of falling asleep, 3 = high probability of falling asleep. The scores will be added up to give a total ranging from 0 - 24 and indicating different levels of excessive daytime sleepiness (6-10 higher than normal; 11-12 mild; 13-15 moderate; 16-24 severe).
Measured: 3 months
Changes in snoring from baseline compared to 3 months follow-up
Changes in snoring assessed with a snoring questionnaire (the Thornton Snoring Scale contains 5 questions about snoring as subjective patient's measure). The Thornton Snoring Scale consists of 5 questions that can be answered with 0 = never, 1 = infrequently, 2 = frequently, 3 = most of the time. The scores will be added and when the sum of all answers is higher than 5, a snoring problem is indicated.
Measured: 3 months
Usage of the MAD (mandibular advancement device)
Patients will be asked about how long and on how many days they were using the Narval MAD during the follow-up period. Patients will be offered a choice between "usage in total" - every night, 3-4 times a week, 1-2 times a week. Usage per night: Less than 1 hour, 1-3 hours, 4-5 hours.
Measured: 3 months
Side effects with use of the MAD (mandibular advancement device)
Patients will be asked if they experienced side effects and which kind of side effects: Temporomandibular joint pain, dental pain, hypersalivation, dry mouth, local irritation, inflammation, dental fracture, broken MAD/device defect.
Measured: 3 months
Document comorbidities of enrolled patients
Patients will be asked for relevant comorbidities (diabetes, hypertension, heart failure)
Measured: 3 months
Remuneration of a MAD
Patients will be asked whether they bought the MAD themselves or if a public or private healthcare insurance provider paid the expenses
Measured: 3 months
Satisfaction with therapy
Patients will be asked to rate their satisfaction with therapy on a scale of 1 (bad) to 10 (very good).
Measured: 3 months
Document sleep disorders of enrolled patients
Sleep disorders will be recorded with a polygraphy or polysomnography (obstructive sleep apnoea, central sleep apnoea)
Measured: 3 months
Continuation of therapy
Patients will be asked if they are going to continue therapy. Reasons for therapy termination shall be recorded
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Feb 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by ResMedThe 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
- 500 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Schoebel, Prof, Principal investigator, Ruhrlandklinik Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924817
- Sponsor's protocol ID
- PATT-OSA_Reg_07082023
- Acronym
- PATT-OSA
- Status last verified
- Aug 2026
- First submitted
- 26 Mar 2019
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstructive Sleep Apnea - PATT-OSA Registry
- ClinicalTrials.gov ID
- NCT03924817
- Acronym / sponsor ID
- PATT-OSA / PATT-OSA_Reg_07082023
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Apr 2019 (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.
During sleep, the muscle tonus in the oropharyngeal space is lost, the tongue might fall back andthe volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. The person asleep might compensate the flow limitation by breathing faster, which causes the soft tissue to vibrate (= snoring). Further narrowing of the airways can lead to obstructive apneas (complete airway collapse and stopping of airflow). First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Since PAP involves wearing a facial mask that applies air pressure into the airways, some patients cannot tolerate this therapy. These patients might be candidates for an alternative treatment approach with a mandibular advancement device (MAD).
Detailed description
During sleep, the muscles in the oropharyngeal space relax, the tongue falls back and the volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. Diminishing airflow can lead to snoring or to the airways collapsing completely (obstructive sleep apnea, OSA). Patients who suffer from OSA have trouble breathing during sleep and will have a disturbed sleep architecture as repeated airway closure causes wake reactions and arousals. This does not only lead to severe daytime sleepiness with high risk of causing car accidents, for instance, but also affects synaptic activity during sleep and the balance of blood gas levels. These factors can have a aggravating effect on blood pressure and worsen the prognosis for cardiovascular comorbidities. First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Positive airway pressure is being applied through a facial mask and some patients cannot tolerate this therapy or refuse it. An alternative treatment approach is by fitting an MAD that the patient wears during sleep. An MAD pushes the lower jar forward and thereby increases the volume of the upper airways, thus preventing them to close. Studies have shown good compliance with MAD therapy and benefits in terms of sleepiness and quality of life. The Narval registry study aims to investigate MAD usage in real life and reasons for non-compliance. The registry aims to record patient characteristics (e.g. comorbidities) and side effects that lead to a termination of therapy, but also how the costs for therapy are split between the patient and public or private health insurance providers and how this affects therapy initiation and usage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible for recruitment are male and female patients of ≥ 18 years who have been diagnosed with OSA and who are not eligible for PAP treatment (no tolerance of PAP therapy, therapy refusal for any reason). Patients who have been prescribed an MAD as treatment for OSA. Patients will be followed in their clinical routine treatment pathway.
Key inclusion criteria (4 listed)
- Prescription of any mandibular advancement device
- Age ≥ 18 years
- Ability to understand the study information and information on usage of personal data
- Signed and dated informed consent
Key exclusion criteria (3 listed)
- Patients with central sleep apnea (central AI > 5/hour)
- Patients with loose teeth and severe parodontitis
- Patients with completely missing teeth or removable tooth replacement, or with a teeth health insufficient to retain an MAD Patients with missing molars Patients with maximum protrusion of less than 5mm
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
Changes of the Apnoea-Hypopnea-Index (AHI) at baseline compared to a follow-up after 3 months
Time frame: 3 months
Changes in the number of apnoeas (cessation of airflow) and hypopneas (reduced airflow) at baseline and at follow-up
10 secondary outcomes
Changes in sleep-related quality of life from baseline compared to 3 months follow-up
Time frame: 3 months
Changes in daytime sleepiness from baseline compared to 3 months follow-up
Time frame: 3 months
Changes in snoring from baseline compared to 3 months follow-up
Time frame: 3 months
Usage of the MAD (mandibular advancement device)
Time frame: 3 months
Side effects with use of the MAD (mandibular advancement device)
Time frame: 3 months
Document comorbidities of enrolled patients
Time frame: 3 months
Remuneration of a MAD
Time frame: 3 months
Satisfaction with therapy
Time frame: 3 months
Document sleep disorders of enrolled patients
Time frame: 3 months
Continuation of therapy
Time frame: 3 months
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 13 Aug 2026.
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.
Christoph Schoebel, Prof principal investigator
Ruhrlandklinik Essen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by ResMed at 4 sites 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 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Changes of the Apnoea-Hypopnea-Index (AHI) at baseline compared to a follow-up after 3 months (time frame: 3 months). 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 13 Aug 2026.