NCT02836041

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2021

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

4.9 years

First QC Date

July 14, 2016

Last Update Submit

May 27, 2021

Conditions

Keywords

assess sleepSleep Deprivation16-866

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.

Behavioral: questionnairesDevice: actigraph

Interventions

questionnairesBEHAVIORAL

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).

Pediatrics cancer patients
actigraphDEVICE

This device reliably measures sleep by monitoring the child's motion.

Pediatrics cancer patients

Eligibility Criteria

Age0 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Chani Traube, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

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

Locations