NCT03875053

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
4.4 years until next milestone

Study Start

First participant enrolled

July 25, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2024

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

February 11, 2019

Last Update Submit

October 2, 2023

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Response to CRT

    Up to 1 year

  • Occurrence of OSA in stage III-IVb patients undergoing CRT

    Up to 1 year

  • OSA rate in locally advanced or metastatic stage head and neck squamous cell carcinoma (HNSCC) patients

    Up to 1 year

Other Outcomes (2)

  • Adherence rate to OSA treatment to 30 days

    Up to 1 year

  • Incidence rate of OSA by MRI neck findings

    Up to 1 year

Study Arms (1)

Monitoring device, Quality of Life Assessment, Questionnaire

EXPERIMENTAL

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.

Diagnostic Test: Monitoring DeviceOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Monitoring DeviceDIAGNOSTIC_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.

Also known as: Monitor
Monitoring device, Quality of Life Assessment, Questionnaire
Quality-of-Life AssessmentOTHER

Ancillary studies

Monitoring device, Quality of Life Assessment, Questionnaire
Questionnaire AdministrationOTHER

Ancillary studies

Monitoring device, Quality of Life Assessment, Questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ammar Sukari, M.D.

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2019

First Posted

March 14, 2019

Study Start

July 25, 2023

Primary Completion

August 24, 2023

Study Completion

August 24, 2024

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)