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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024386

Enrollment

Registered

2021-02-19

Start date

2021-03-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

G47.31 J34.2

Interventions

Group 1: Patients who are planning to undergo rhinosurgery and who use auto-CPAP therapy will receive a polysomnographically assisted auto-CPAP check with pressure limits of 4-18 mbar at the start of

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. 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)).	—

Measure

Time frame

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. 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)).

—

Countries

Germany

Outcome results

None listed

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