Effectiveness of relocation pharyngoplasty in obstructive sleep apnea

Not Applicable

Conditions: G47.31

Registration Number: DRKS00025474

Lead Sponsor: Bundeswehrkrankenhaus Ulm Abteilung Hals-, Nasen- und Ohrenheilkunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients with obstructive sleep apnea in need of therapy according to the above criteria of the American Academy of Sleep Medicine (AASM) are included. The patients are aware of their illness and agree to participate in the study and to carry out the surgical procedure and were informed about its risks, complications and alternatives, usually as part of an outpatient stay and at least as part of the pre-hospital admission. The information about the study and the consent to participate in it takes place either as part of the inpatient admission or already as part of the outpatient, sleep medical consultation.

Exclusion Criteria

Patients with a body mass index over 34 kg / m² will be excluded from participating in the study, as surgical therapy methods for reducing obstructive sleep apnea have proven to be ineffective. Likewise, patients with a history of head and neck cancer, previous surgical interventions on the soft palate or tonsils, or pure rhonchopathy (without additional obstructive sleep apnea) are excluded. Serious malformations in the midface such as cleft lip and palate also lead to non-inclusion in the study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary target parameter for measuring the success of the operation is the AHI and, derived from this, the Sher criteria (T. Verse, 2017). These state that (in 50% of patients) the AHI falls by 50% and below 20 / h.

Secondary Outcome Measures

Name	Time	Method
The decrease in further polysomnographically ascertained parameters such as the ODI / RDI as well as the change from a sleep-related obstructive breathing disorder that no longer needs therapy is also recorded. Likewise, the level of daytime sleepiness and patient satisfaction measured in questionnaires (e.g. ESS, FOSQ) should be recorded pre- and post-operatively.<br><br>