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

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.

Study Overview

• Status: Withdrawn
• Conditions: Metastatic Head and Neck Squamous Cell Carcinoma; Locally Advanced Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Diagnostic test: Monitoring Device

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ammar Sukari, M.D.; Phone Number: 313-576-8778; Email: sukaria@karmanos.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monitoring device, Quality of Life Assessment, Questionnaire; 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; 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 Names: Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obstructive sleep apnea (OSA) rate before and after chemoradiation therapy (CRT) in stage III-IVb patients undergoing CRT	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.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to CRT	Will be evaluated using Response Evaluation Criteria in Solid Tumors version 1.1. Will be described by mean and the two-sided CI. The univariable and multivariable binary (multinomial) logistic regression models will be used to assess the association of the effects of patients' baseline characteristics and the occurrence of OSA on the CRT responses.	Up to 1 year
Occurrence of OSA in stage III-IVb patients undergoing CRT	Will be grouped into four categories (Yes/Yes, Yes/No, No/Yes, and No/No for pre/post CRT). Then a 2x4 contingency table will be generated by CRT response (binary; Yes vs. No) and OSA occurrence (quaternary; Yes/Yes vs. Yes/No vs. No/Yes vs. No/No) and a Chi- 23 squared test (or Fisher's exact test) will be used. The univariable and multivariable binary (multinomial) logistic regression models will be used to assess the association of the effects of patients' baseline characteristics and the occurrence of OSA on the CRT responses.	Up to 1 year
OSA rate in locally advanced or metastatic stage head and neck squamous cell carcinoma (HNSCC) patients	A descriptive analysis will be performed on all patients enrolled and on all eligible patients who undergo home sleep apnea study to evaluate the OSA rate in locally advanced or metastatic stage HNSCC patients. The OSA rate will be estimated for locally advanced or metastatic stage HNSCC patients who enter the study in Part 1 and then will be described by mean and the two-sided Cl.	Up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence rate to OSA treatment to 30 days	It is defined as the ratio of the number of days adhered to OSA treatment to 30 days.	Up to 1 year
Incidence rate of OSA by MRI neck findings	It is the OSA rate detected by MRI neck findings among oropharyngeal cancer patients.	Up to 1 year

Collaborators and Investigators

• Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ammar Sukari, M.D., Barbara Ann Karmanos Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): July 25, 2023
• Primary Completion (Estimated): August 24, 2023
• Study Completion (Estimated): August 24, 2024

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Head and Neck Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: 2017-135; P30CA022453 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes