Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstructive Sleep Apnea - PATT-OSA Registry (PATT-OSA)

August 11, 2023 updated by: ResMed
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).

Study Overview

Status

Not yet recruiting

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Berlin, Germany, 12683
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg - Klinik für Innere Medizin II
        • Contact:
    • Badden-Württemberg
      • Blaubeuren, Badden-Württemberg, Germany, 89143
    • Nordrhein-Westfalen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in sleep-related quality of life from baseline compared to 3 months follow-up
Time Frame: 3 months
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.
3 months
Changes in daytime sleepiness from baseline compared to 3 months follow-up
Time Frame: 3 months
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).
3 months
Changes in snoring from baseline compared to 3 months follow-up
Time Frame: 3 months
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.
3 months
Document comorbidities of enrolled patients
Time Frame: 3 months
Patients will be asked for relevant comorbidities (diabetes, hypertension, heart failure)
3 months
Satisfaction with therapy
Time Frame: 3 months
Patients will be asked to rate their satisfaction with therapy on a scale of 1 (bad) to 10 (very good).
3 months
Document sleep disorders of enrolled patients
Time Frame: 3 months
Sleep disorders will be recorded with a polygraphy or polysomnography (obstructive sleep apnoea, central sleep apnoea)
3 months
Continuation of therapy
Time Frame: 3 months
Patients will be asked if they are going to continue therapy. Reasons for therapy termination shall be recorded
3 months
Usage of the MAD (mandibular advancement device)
Time Frame: 3 months
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.
3 months
Side effects with use of the MAD (mandibular advancement device)
Time Frame: 3 months
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.
3 months
Remuneration of a MAD
Time Frame: 3 months
Patients will be asked whether they bought the MAD themselves or if a public or private healthcare insurance provider paid the expenses
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Christoph Schoebel, Prof, Ruhrlandklinik Essen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Sleep Apnea

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