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

NCT03924817 | Recruiting

• 1 other identifier: PATT-OSA_Reg_07082023
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Changes in sleep-related quality of life from baseline compared to 3 months follow-up

  3 months

• Changes in daytime sleepiness from baseline compared to 3 months follow-up

  3 months

• Changes in snoring from baseline compared to 3 months follow-up

  3 months

• Usage of the MAD (mandibular advancement device)

  3 months

• Side effects with use of the MAD (mandibular advancement device)

  3 months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (4)

Schlaf- und Beatmungszentrum Blaubeuren

Blaubeuren Abbey, Badden-Württemberg, 89143, Germany

NOT YET RECRUITING

Ruhrlandklinik Essen

Essen, North Rhine-Westphalia, 45239, Germany

RECRUITING

Zentrum für Schlafmedizin Dr. Warmuth

Berlin, 12683, Germany

NOT YET RECRUITING

Universitätsklinikum Regensburg - Klinik für Innere Medizin II

Regensburg, 93053, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Christoph Schoebel, Prof

  Ruhrlandklinik Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Munt, PhD

CONTACT

+491629056360; oliver.munt@resmed.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 23, 2019
• Study Start: February 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

DE (4)