Sleep in Hospitalized Children at MSKCC

Pediatric Cancer Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836041
• Other study ID #: 16-866
• Status: Completed
• Start date: July 7, 2016
• Est. completion date: May 26, 2021

Study information

• Verified date: May 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 26, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pediatric Cancer Patients

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Johns Hopkins University, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of sleep	(using the Sleep at MSK questionnaire)	3 nights

External Links

•   Memorial Sloan Kettering Cancer Center