Malignant Head and Neck NeoplasmNCT05108233
Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course
An observational study of Malignant Head and Neck Neoplasm, run by Thomas Jefferson University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Head and Neck Neoplasm
- What is being tested?
- Survey Administration
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with head and neck cancer
Who may be able to join
- 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
Who cannot join
- Non-English speaking
- Pre-existing sleep disorder defined below:
- Obstructive sleep apnea
- Insomnia
- Narcolepsy
- Restless leg syndrome
- Rapid eye movement (REM) sleep behavior disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To describe the five (5) components of sleep quality in head and neck patients under different stages of post-op treatment and different environment.
II. To evaluate the effect of surgery, treatment and environment on the five (5) components of sleep quality in head and neck cancer patients.
SECONDARY OBJECTIVES:
- To evaluate the association between the five (5) components of sleep quality and comorbid obstructive sleep apnea (STOP-BANG and Epworth Sleeping Scale) and depression (Patient Health Questionnaire-2 [PHQ-2]), under different stages of post-op treatment and different environment.
II. To evaluate the association between Fitbit actigraphy data (i.e. the 5th component of sleep quality) and the first 4 components of sleep quality for inpatients.
III. To compare the inpatient versus the outpatient responses on sleep hygiene at different time points of measurement.
EXPLORATORY OBJECTIVE:
- To assess whether survey results warrant additional counseling or patient education.
OUTLINE:
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.
- Conditions
- Malignant Head and Neck Neoplasm
- Being tested
- Survey Administration
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in bed
The time difference between time to get into bed and time to get up, measured in minutes
Measured: Up to study completion; approximately 12 months
Sleep latency
How long it takes to sleep, measured in minutes.
Measured: Up to study completion; approximately 12 months
Number of nighttime awakening
Measured: Up to study completion; approximately 12 months
Sleep maintenance latency
How long it takes to fall back to sleep, measured in minutes.
Measured: Up to study completion; approximately 12 months
Per-patient average score on Richards-Campbell Sleep Questionnaire
Measured: Up to study completion; approximately 12 months
Sleep hygiene
Measured: Up to study completion; approximately 12 months
Barriers to sleep quality
Measured: Up to study completion; approximately 12 months
Per-patient sum of scores on Epworth Sleepiness Scale
Measured: Up to study completion; approximately 12 months
Per-patient sum of positive responses on STOP-BANG
Measured: Up to study completion; approximately 12 months
Per-patient sum of scores on Patient Health Questionnaire-2
Measured: Up to study completion; approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Jan 2022
- Primary completion24 Oct 2024
- Study completion1 Dec 2025 (estimated)
Why it stopped: PI agreed to close study as prompted by PRMC inquiry
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Head and Neck NeoplasmStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108233
- Sponsor's protocol ID
- 21D.668
- Other IDs
- JT 16663
- Status last verified
- Sep 2025
- First submitted
- 4 Oct 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course
- ClinicalTrials.gov ID
- NCT05108233
- Acronym / sponsor ID
- 21D.668
- Conditions
- Malignant Head and Neck Neoplasm
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI agreed to close study as prompted by PRMC inquiry
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To describe the five (5) components of sleep quality in head and neck patients under different stages of post-op treatment and different environment.
II. To evaluate the effect of surgery, treatment and environment on the five (5) components of sleep quality in head and neck cancer patients.
SECONDARY OBJECTIVES:
- To evaluate the association between the five (5) components of sleep quality and comorbid obstructive sleep apnea (STOP-BANG and Epworth Sleeping Scale) and depression (Patient Health Questionnaire-2 [PHQ-2]), under different stages of post-op treatment and different environment.
II. To evaluate the association between Fitbit actigraphy data (i.e. the 5th component of sleep quality) and the first 4 components of sleep quality for inpatients.
III. To compare the inpatient versus the outpatient responses on sleep hygiene at different time points of measurement.
EXPLORATORY OBJECTIVE:
- To assess whether survey results warrant additional counseling or patient education.
OUTLINE:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey) | – | Other: Survey AdministrationCOHORT 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with head and neck cancer
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- Non-English speaking
- Pre-existing sleep disorder defined below:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey AdministrationComplete survey | Other | Observational (survey) |
Primary outcome
Time in bed
Time frame: Up to study completion; approximately 12 months
The time difference between time to get into bed and time to get up, measured in minutes
Sleep latency
Time frame: Up to study completion; approximately 12 months
How long it takes to sleep, measured in minutes.
Number of nighttime awakening
Time frame: Up to study completion; approximately 12 months
Sleep maintenance latency
Time frame: Up to study completion; approximately 12 months
How long it takes to fall back to sleep, measured in minutes.
Per-patient average score on Richards-Campbell Sleep Questionnaire
Time frame: Up to study completion; approximately 12 months
Sleep hygiene
Time frame: Up to study completion; approximately 12 months
Barriers to sleep quality
Time frame: Up to study completion; approximately 12 months
Per-patient sum of scores on Epworth Sleepiness Scale
Time frame: Up to study completion; approximately 12 months
Per-patient sum of positive responses on STOP-BANG
Time frame: Up to study completion; approximately 12 months
Per-patient sum of scores on Patient Health Questionnaire-2
Time frame: Up to study completion; approximately 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
Related trials for Malignant Head and Neck Neoplasm
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Head and Neck Neoplasm, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in bed (time frame: Up to study completion; approximately 12 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.