Modification of the necessary therapeutic ventilation pressure for auto-CPAP therapy by surgical treatment of nasal breathing obstruction in patients with obstructive sleep apnea.

Not Applicable

• Conditions: G47.31; J34.2; Deviated nasal septum

• Registration Number: DRKS00024386
• Lead Sponsor: Sektion für SchlafmedizinKlinik für Hals- Nasen- Ohrenheilkunde, Kopf- und Halschirurgie Universitätsmedizin Mannheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Patients with obstructive sleep apnea who are treated with auto-CPAP therapy.

These patients have nasal obstruction.

Surgical improvement of nasal breathing is planned.

The patient is able to give consent

Age at least 18 years

Exclusion Criteria

Therapy using another method of positive pressure therapy (e.g. CPAP)

simultaneous participation in another clinical trial

Friedman Grade 3 or 4 tonsil hyperplasia

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary target parameter is the necessary pressure for the auto-CPAP therapy. The pressure percentile p95 found in the APAP titration is the primary target parameter during polysomnography.

Secondary Outcome Measures

Name	Time	Method
Further pressure parameters: pressure percentile p50 and maximum pressure during polysomnography. Pressure percentiles p50, p95 and maximum pressure within the last month before the polysomnography.<br>Furthermore, it will be investigated whether the surgical improvement of nasal breathing leads to an increase in the tolerance and use of auto-CPAP therapy. The objective use in average hours per night and night per week within the last month before the polysomnography, the formation of leaks on the mask (p50 and p95), the type of mask used, the use of a warm air humidifier and various sleep parameters (apnea-hypopnea- Index (AHI), Respiratory disturbance index (RDI), mean oxygen saturation, deepest desaturation, Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI)).