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

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ClinicalTrials.gov Identifier: NCT03875053
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Misako Nagasaka, Barbara Ann Karmanos Cancer Institute

Tracking Information
First Submitted Date  ICMJE February 11, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 14, 2019
Estimated Study Start Date  ICMJE March 20, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
Obstructive sleep apnea (OSA) rate before and after chemoradiation therapy (CRT) in stage III-IVb patients undergoing CRT [ Time Frame: Up to 1 year ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Response to CRT [ Time Frame: Up to 1 year ]
    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.
  • Occurrence of OSA in stage III-IVb patients undergoing CRT [ Time Frame: Up to 1 year ]
    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.
  • OSA rate in locally advanced or metastatic stage head and neck squamous cell carcinoma (HNSCC) patients [ Time Frame: Up to 1 year ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 12, 2019)
  • Adherence rate to OSA treatment to 30 days [ Time Frame: Up to 1 year ]
    It is defined as the ratio of the number of days adhered to OSA treatment to 30 days.
  • Incidence rate of OSA by MRI neck findings [ Time Frame: Up to 1 year ]
    It is the OSA rate detected by MRI neck findings among oropharyngeal cancer patients.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Home Sleep Apnea Machine in Evaluating Obstructive Sleep Apnea in Patients With Stage III-IV Head and Neck Cancer
Official Title  ICMJE Evaluation of Obstructive Sleep Apnea in Head and Neck Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Advanced Head and Neck Squamous Cell Carcinoma
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
  • Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Intervention  ICMJE
  • 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 Name: Monitor
  • Other: Quality-of-Life Assessment
    Ancillary studies
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE 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.
Interventions:
  • Diagnostic Test: Monitoring Device
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2019)
59
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Misako Nagasaka, M.D. 313-576-8753 nagasakm@karmanos.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03875053
Other Study ID Numbers  ICMJE 2017-135
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Misako Nagasaka, Barbara Ann Karmanos Cancer Institute
Study Sponsor  ICMJE Barbara Ann Karmanos Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Misako Nagasaka, M.D. Barbara Ann Karmanos Cancer Institute
PRS Account Barbara Ann Karmanos Cancer Institute
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP