Detection of potential adverse orofacial side effects in patients with obstructive sleep apnoea and hypoglossal nerve stimulation therapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033378

Enrollment

Registered

2024-01-10

Start date

2023-12-18

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G47.31

Interventions

Group 1: Patients with obstructive sleep apnea undergoing hypoglossal nerve stimulation therapy are recruited and examined to evaluate potential undesired orofacial side effects. A total of six assess

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: • Presence of anterior teeth in the upper and lower jaws • Signed informed consent form available

Exclusion criteria

Exclusion criteria: Lack of informed consent to participate in the study • Combination therapy with CPAP or mandibular advancement device • Absence of incisors in the upper and lower jaw • Generalized severe periodontitis • Nighttime use of a bite splint • Fixed retainer in the upper and lower jaw

Design outcomes

Primary

Measure	Time frame
Assessment of changes in overjet, overbite, and occlusal contacts associated with tongue activity and decrease in oral health-related quality of life among patients with hypoglossal stimulation therapy over a three-year observation period.	—

Secondary

Measure	Time frame
Dependence of objective and subjective changes over the three-year course of treatment on the stimulation intensity of the hypoglossal nerve stimulator.	—

Countries

Germany

Contacts

Public ContactJanine Sambale

Philipps-Universität Marburg

sambale@staff.uni-marburg.de+49 6421/58-63220

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026