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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-25

Study Completion Date

2024-08-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sleep Apnea in Head and Neck Cancer Patients at the University of Colorado

NCT04922112

Obstructive Sleep Apnea Squamous Cell Carcinoma of Head and Neck

WITHDRAWN NA

Innovative OSA Screening in Head and Neck Cancer Patients With the Apneal App

NCT06896448

Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Head and Neck Cancers

NOT_YET_RECRUITING NA

Obstructive Apnea in Patients Submitted to Partial Laryngectomy

NCT01157286

OBSTRUCTIVE SLEEP APNEA

UNKNOWN

Evaluating Accuracy of Breath Sound Recordings and STOP-Bang Screening For Obstructive Sleep Apnea While Awake

NCT02987283

Sleep Apnea, Obstructive

COMPLETED

High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea

NCT03017859

Sleep Apnea, Obstructive

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Monitoring Device

Intervention Type DIAGNOSTIC_TEST

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.

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Monitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No