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Effectiveness of relocation pharyngoplasty in obstructive sleep apnea

Effectiveness of relocation pharyngoplasty in obstructive sleep apnea

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025474
Enrollment
50
Registered
2021-06-16
Start date
2021-06-27
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

Interventions

Group 1: relocationpharyngoplasty incl. tonsillectomy

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactTheo Evers

Bundeswehrkrankenhaus Ulm Abteilung Hals-, Nasen- und Ohrenheilkunde

theoevers@bundeswehr.org0731/ 1710- 34616

Outcome results

None listed

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