Diagnosis and treatment of obstructive sleep apnoea in patients with head and neck squamous cell carcinoma treated primary chemo/radiation therapy

Diagnosis and treatment of obstructive sleep apnoea in patients with head and neck squamous cell carcinoma treated primary chemo/radiation therapy - KKHR OSA RCT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021731

Enrollment

220

Registered

2020-05-26

Start date

2020-09-01

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

G47.3 C13 C14

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 primary 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 end of radiation therapy (after 6 weeks), during follow up (after 3 and 6 months)	—

Secondary

Measure	Time frame
apnea / hypopnea index (AHI) Epworth Sleepiness Scale (ESS) EORTC QLQ c30 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

Universitätsmedzin Mainz

poliklinik-hno@unimedizin-mainz.de0049 6131 17-0

Outcome results

None listed

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