Home Sleep Apnea Machine in Evaluating Obstructive Sleep Apnea in Patients With Stage III-IV Head and Neck Cancer

Barbara Ann Karmanos Cancer Institute

Status: Withdrawn

Conditions: Metastatic Head and Neck Squamous Cell Carcinoma; Locally Advanced Head and Neck Squamous Cell Carcinoma

Treatments: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Diagnostic Test: Monitoring Device

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03875053

P30CA022453 (U.S. NIH Grant/Contract)

2017-135

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Monitoring device, Quality of Life Assessment, Questionnaire

Experimental group

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.

Treatment:

Diagnostic Test: Monitoring Device

Other: Questionnaire Administration

Other: Quality-of-Life Assessment