Sleep in Hospitalized Children at MSKCC
A Pilot Study: Sleep in Hospitalized Children With Cancer and Related Diseases
1 other identifier
observational
66
1 country
1
Brief Summary
The investigators want to better understand how children sleep at night at MSKCC, so that the investigators can learn how to improve the sleeping environment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2016
CompletedFirst Submitted
Initial submission to the registry
July 14, 2016
CompletedFirst Posted
Study publicly available on registry
July 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2021
CompletedMay 28, 2021
May 1, 2021
4.9 years
July 14, 2016
May 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
quality of sleep
(using the Sleep at MSK questionnaire)
3 nights
Study Arms (1)
Pediatrics cancer patients
Eligible patients will be approached for enrollment after their first night in the hospital (i.e.: not on day of admission). Patient/parent will be asked to complete a brief questionnaire describing the child's general sleep habits prior to admission. The parent and/or child will then be asked to complete a questionnaire describing sleep while in the hospital; this in-hospital sleep questionnaire will be obtained for 3 consecutive nights after enrollment, or until discharge, whichever is soonest. A subgroup of patients (between the ages of 5 and 18) will be invited to participate in an additional aspect of the study, where they wear an actigraph (a small device that looks like a watch) for up to 72 hours. This device reliably measures sleep by monitoring the child's motion. This will be used to relate sleep perception to more objective measures of sleep as provided by actigraphy.
Interventions
Pre-hospital sleep questionnaire completed (Brief Infant Sleep Questionnaire (BISQ)7 in children 0-3 years old; Children's Sleep Habits Questionnaire (CSHQ)8 in children 4 years and older). Subsequent Day(s): In-hospital sleep questionnaire completed between one and three times per subject (Sleep at MSK questionnaire (SAM), adapted from Sleep in a Children's Hospital (SinCH)9 by Dr. Lisa Meltzer). (Patients will be observed for up to 3 consecutive nights in total).
This device reliably measures sleep by monitoring the child's motion.
Eligibility Criteria
All eligible patients admitted to the pediatric floor at MSK.
You may qualify if:
- Parent/Patient must provide written consent
- Patient must be between the ages of: Newborn - ≤ 18 years of age
- Patient is expected to be admitted to the Pediatric floor at MSK for at least 2 nights (patients/parents will not be approached for consent on day of admission or day of discharge)
- Patient/parent must be English speaking
You may not qualify if:
- Expected length of stay of fewer than 2 nights (for example.: if admitted Monday and discharged Tuesday, patient/parent will not be eligible).
- Patient /Parent unable to complete questionnaire due to education or language barriers.
- Patients admitted to the PICU. (Only children on M9 will be included. It is known that sleep in the PICU is highly disordered; as such, we will be excluding PICU patients from this study).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Johns Hopkins Universitycollaborator
- Weill Medical College of Cornell Universitycollaborator
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chani Traube, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2016
First Posted
July 18, 2016
Study Start
July 7, 2016
Primary Completion
May 26, 2021
Study Completion
May 26, 2021
Last Updated
May 28, 2021
Record last verified: 2021-05