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

Obstructive Sleep Apnea Clinical Trial

— PATT-OSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03924817
• Other study ID #: PATT-OSA_Reg_07082023
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: ResMed
• Contact: Oliver Munt, PhD
• Phone: +491629056360
• Email: oliver.munt[@]resmed.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Germany	Zentrum für Schlafmedizin Dr. Warmuth	Berlin
Germany	Schlaf- und Beatmungszentrum Blaubeuren	Blaubeuren	Badden-Württemberg
Germany	Ruhrlandklinik Essen	Essen	Nordrhein-Westfalen
Germany	Universitätsklinikum Regensburg - Klinik für Innere Medizin II	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	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.	3 months
Secondary	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).	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	Document comorbidities of enrolled patients	Patients will be asked for relevant comorbidities (diabetes, hypertension, heart failure)	3 months
Secondary	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	3 months
Secondary	Satisfaction with therapy	Patients will be asked to rate their satisfaction with therapy on a scale of 1 (bad) to 10 (very good).	3 months
Secondary	Document sleep disorders of enrolled patients	Sleep disorders will be recorded with a polygraphy or polysomnography (obstructive sleep apnoea, central sleep apnoea)	3 months
Secondary	Continuation of therapy	Patients will be asked if they are going to continue therapy. Reasons for therapy termination shall be recorded	3 months