Sleep in Hospitalized Children at MSKCC

May 27, 2021 updated by: Memorial Sloan Kettering Cancer Center

A Pilot Study: Sleep in Hospitalized Children With Cancer and Related Diseases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All eligible patients admitted to the pediatric floor at MSK.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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: questionnaires

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).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of sleep
Time Frame: 3 nights
(using the Sleep at MSK questionnaire)
3 nights

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Johns Hopkins University
Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Chani Traube, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2016

Primary Completion (Actual)

May 26, 2021

Study Completion (Actual)

May 26, 2021

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 28, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-866

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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