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Sleep in Hospitalized Children at MSKCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836041
Recruitment Status : Active, not recruiting
First Posted : July 18, 2016
Last Update Posted : September 21, 2020
Sponsor:
Collaborators:
Johns Hopkins University
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Pediatric Cancer Patients Behavioral: questionnaires Device: actigraph

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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study: Sleep in Hospitalized Children With Cancer and Related Diseases
Study Start Date : July 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. quality of sleep [ Time Frame: 3 nights ]
    (using the Sleep at MSK questionnaire)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All eligible patients admitted to the pediatric floor at MSK.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836041


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Johns Hopkins University
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Chani Traube, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02836041    
Other Study ID Numbers: 16-866
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
assess sleep
Sleep Deprivation
16-866