Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course

NCT05108233 | Withdrawn

• 2 other identifiers: 21D.668JT 16663
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines how head and neck cancer treatment affects quality of sleep over time and factors that contribute to sleep quality. Sleep plays a critical role in healing and quality of life, and recent studies investigating sleep disorders in head and neck cancer patients reveal sleep quality is a major determinant of post-treatment outcomes. Information from this study may help researchers better understand how treatment impacts sleep quality so that they can make changes that may help improve patient sleep quality.

Conditions

Malignant Head and Neck Neoplasm

Outcome Measures

Primary Outcomes (10)

• Time in bed

  The time difference between time to get into bed and time to get up, measured in minutes

  Up to study completion; approximately 12 months

• Sleep latency

  How long it takes to sleep, measured in minutes.

  Up to study completion; approximately 12 months

• Number of nighttime awakening

  Up to study completion; approximately 12 months

• Sleep maintenance latency

  How long it takes to fall back to sleep, measured in minutes.

  Up to study completion; approximately 12 months

• Per-patient average score on Richards-Campbell Sleep Questionnaire

  Up to study completion; approximately 12 months

• Sleep hygiene

  Up to study completion; approximately 12 months

• Barriers to sleep quality

  Up to study completion; approximately 12 months

• Per-patient sum of scores on Epworth Sleepiness Scale

  Up to study completion; approximately 12 months

• Per-patient sum of positive responses on STOP-BANG

  Up to study completion; approximately 12 months

• Per-patient sum of scores on Patient Health Questionnaire-2

  Up to study completion; approximately 12 months

Study Arms (1)

Observational (survey)

COHORT 1-TP1: Patients complete surveys over 20 minutes on post-op day 3 and on day of discharge (or within 1 week). COHORT 1-TP2: Patients complete surveys over 15 minutes at all regularly scheduled follow-up appointments (approximately 1 month, 3 months, 6 months, 12 months). COHORT 2: Patients complete surveys over 15 minutes once.

Other: Survey Administration

Interventions

Survey Administration OTHER

Complete survey

Observational (survey)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with head and neck cancer

You may qualify if:

• Males and females
• Adult at least 18 years old
• Capable of giving informed consent
• Diagnosed with head and neck cancer (previously untreated, any stage)
• Treatment plan involves surgery
• Willing to comply with all study procedures and be available for the duration of the study
• English-speaking

You may not qualify if:

• Non-English speaking
• Pre-existing sleep disorder defined below:
• Obstructive sleep apnea
• Insomnia
• Narcolepsy
• Restless leg syndrome
• Rapid eye movement (REM) sleep behavior disorder

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: November 4, 2021
• Study Start: January 1, 2022
• Primary Completion: October 24, 2024
• Study Completion: December 1, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)