Clinical trial · Interventional
Home Sleep Apnea Machine in Evaluating Obstructive Sleep Apnea in Patients With Stage III-IV Head and Neck Cancer
Evaluation of Obstructive Sleep Apnea in Head and Neck Cancer
NCT03875053CI-TRIAL-00070176withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No accrual
Summary
Brief summary (as posted)
This trial studies information from a home sleep apnea machine to evaluate obstructive sleep apnea in patients with stage III-IV head and neck cancer. Sleep apnea (trouble breathing during sleep) can occur in head and neck cancer patients who have swelling in their neck. Wearing a sleep apnea machine overnight may help doctors evaluate obstructive sleep apnea in patients with head and neck cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Monitoring Device | Diagnostic Test | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Monitoring device, Quality of Life Assessment, Questionnaire
- description
- Patients wear the home sleep apnea machine overnight. Patients undergoing standard of care CRT wear the home sleep apnea machine a second time 3 months after completion of CRT.
- interventionNames
- Diagnostic Test: Monitoring Device
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Obstructive sleep apnea (OSA) rate before and after chemoradiation therapy (CRT) in stage III-IVb patients undergoing CRT
- timeFrame
- Up to 1 year
- description
- The definition of OSA will be defined as apnea-hypopnea index of \> 5 for both pre and post CRT. The OSA rate is the proportion of patients diagnosed with OSA. Will be assessed using a two-sided McNemar test based on the OSA occurrence (Yes versus \[vs.\] No) for each patient. The OSA rates pre and post CRT will be described by means and their two-sided confidence intervals (Cls). The univariable and multivariable conditional logistic regression models will be further used for the primary objective with patients' baseline characteristics as covariates.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced (stage III-IVb) and metastatic (stage IVc) HNSCC who are referred to medical oncology. Patients may not have received upfront definitive surgical resection of the primary tumor or upfront neck dissection. * Patients must be able to operate the home sleep study device. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Exclusion Criteria: * Patients should not have received any prior systemic chemotherapy or radiation therapy for locally advanced or metastatic HNSCC. * Patients with tracheostomy or those requiring the assistance of a ventilator will be ineligible for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.