Analysis of the Therapeutic Effectiveness of Mandibular Advancement Devices Compared to CPAP Therapy in Patients with Obstructive Sleep Apnea

Analysis of the Therapeutic Effectiveness of Mandibular Advancement Devices Compared to CPAP Therapy in Patients with Obstructive Sleep Apnea - UKPS-CPAP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036815

Enrollment

150

Registered

2025-05-05

Start date

2025-04-20

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Obstructive Sleep Apnea Syndrome (OSAS)

Interventions

Group 1: Mandibular Advancement Device (MAD) Therapy Patients in this arm were treated with a custom-fitted mandibular advancement device (MAD) as part of routine clinical care. The fabrication and us

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients (=18 years) diagnosed with obstructive sleep apnea (OSA) • Available polysomnographic or polygraphic data including Apnea-Hypopnea Index (AHI) • Treatment with either CPAP or mandibular advancement device (MAD) • Availability of AHI values before and after therapy

Exclusion criteria

Exclusion criteria: Central or mixed sleep apnea • Missing or incomplete documentation of relevant parameters (AHI) • Change of therapy modality during a single treatment phase

Design outcomes

Primary

Measure	Time frame
Change in Apnea-Hypopnea Index (AHI) The primary outcome is the change in the Apnea-Hypopnea Index (AHI) before and with therapy with either CPAP or mandibular advancement device (MAD). The AHI is assessed based on polysomnographic data.	—

Secondary

Measure	Time frame
• Change in daytime sleepiness (Epworth Sleepiness Scale – ESS): Evaluation of changes in subjective daytime sleepiness using the Epworth Sleepiness Scale (ESS) before and with each treatment phase. • Change in Body Mass Index (BMI): Assessment of BMI changes between the beginning and with each treatment phase. • Positional dependency of obstructive events (supine vs. non-supine position): Analysis of the relationship between treatment response and the patient’s sleeping position, with a focus on supine-related obstructive events.	—

Measure

Time frame

• Change in daytime sleepiness (Epworth Sleepiness Scale – ESS): Evaluation of changes in subjective daytime sleepiness using the Epworth Sleepiness Scale (ESS) before and with each treatment phase. • Change in Body Mass Index (BMI): Assessment of BMI changes between the beginning and with each treatment phase. • Positional dependency of obstructive events (supine vs. non-supine position): Analysis of the relationship between treatment response and the patient’s sleeping position, with a focus on supine-related obstructive events.

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Countries

Germany

Contacts

Public ContactChristian Offergeld

Uniklinik Freiburg

christian.offergeld@uniklinik-freiburg.de0761 27042010

Outcome results

None listed

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