Diagnosis and treatment of obstructive sleep apnoea in patients with head and neck squamous cell carcinoma treated with surgery and adjuvant radiation therapy

Diagnosis and treatment of obstructive sleep apnoea in patients with head and neck squamous cell carcinoma treated with surgery and adjuvant radiation therapy - KKHR-OSA-Surg

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021692

Enrollment

220

Registered

2020-05-26

Start date

2020-09-18

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

G47.3 C14 C13

Interventions

Group 1: After 2:1 randomisation aPAP-therapy (auto-titrated positive airway pressure therapy) is used during radiation (6 weeks) and for the following 6 months. Masks should be worn for at least 5 ho

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: - Patients with cT2- cT4 head and neck cancer - Cancer localization oral, oropharynx, hypopharynx - Indication to surgery and adjuvant radiochemotherapy - Age 18 years and older

Exclusion criteria

Exclusion criteria: - Tracheostomy for the duration of the RCT - Laryngectomy - Missing informed consent - Congestive heart failure (EF 38 Kg/m²

Design outcomes

Primary

Measure	Time frame
Symptomscale fatigue EORTC QLQ C 30 Before therapy (point in time 0), after surgery (after 2 weeks), after end of adjuvant therapy (after 8 weeks), during follow up (after 3 and 6 months)	—

Secondary

Measure	Time frame
EORTC symptom scales Apnea / hypopnea index (AHI) Epworth Sleepiness Scale (ESS) Pittsburgh Sleep Quality Index (PSQI) Insomnia Severity Index (ISI) CT-scan-based tumor dimensions Before therapy, after surgery, after end of adjuvant therapy, during follow up	—

Countries

Germany

Contacts

Public ContactTilman Huppertz

Universitätsmedizin Mainz

poliklinik-hno@unimedizin-mainz.de06131 17-0

Outcome results

None listed

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