NCT03875053

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a single center study in HNSCC subjects to assess the effects of CRT on OSA.. Patients will be screened with a physical exam and questionnaire (The Berlin questionnaire, STOP-BANG, PSQI) and when eligible, will have the home sleep study (Specific aim 1). The low risk group (based on the physical exam and questionnaire) with stage IVc will not be eligible for the home sleep study and will concentrate on palliation of their symptoms. For locally advanced HNSCC patients undergoing definitive CRT, post CRT home sleep study results will also be assessed (Specific aim 2). When the patient is diagnosed with OSA based on the home sleep study, or if the home sleep study is negative but if the patient had high risks based on the screening process, the patient will be referred to the sleep medicine clinic. If life-threatening obstructive sleep apnea is found, the patient will be referred to sleep medicine clinic right away and will be taken off study. Otherwise, the patients will prioritize their definitive CRT for HNSCC, and will be referred to sleep medicine clinic once CRT has been completed.

Conditions

• Locally Advanced Head and Neck Squamous Cell Carcinoma
• Metastatic Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Monitoring Device	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.
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2023-07-25
• Primary completion: 2023-08-24
• Completion: 2024-08-24
• First posted: 2019-03-14
• Last updated: 2023-10-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study