Malignant Head and Neck Neoplasm Clinical Trial
Official title:
Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course
NCT number | NCT05108233 |
Other study ID # | 21D.668 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2022 |
Est. completion date | December 1, 2025 |
Verified date | March 2024 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Non-English speaking - Pre-existing sleep disorder defined below: - Obstructive sleep apnea - Insomnia - Narcolepsy - Restless leg syndrome - Rapid eye movement (REM) sleep behavior disorder |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Sleep latency | How long it takes to sleep, measured in minutes. | Up to study completion; approximately 12 months | |
Primary | Number of nighttime awakening | Up to study completion; approximately 12 months | ||
Primary | Sleep maintenance latency | How long it takes to fall back to sleep, measured in minutes. | Up to study completion; approximately 12 months | |
Primary | Per-patient average score on Richards-Campbell Sleep Questionnaire | Up to study completion; approximately 12 months | ||
Primary | Sleep hygiene | Up to study completion; approximately 12 months | ||
Primary | Barriers to sleep quality | Up to study completion; approximately 12 months | ||
Primary | Per-patient sum of scores on Epworth Sleepiness Scale | Up to study completion; approximately 12 months | ||
Primary | Per-patient sum of positive responses on STOP-BANG | Up to study completion; approximately 12 months | ||
Primary | Per-patient sum of scores on Patient Health Questionnaire-2 | Up to study completion; approximately 12 months |
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