NCT05879640

Brief Summary

This study tests a pilot educational sleep intervention for children after critical care hospitalization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

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

April 18, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

May 18, 2023

Last Update Submit

April 15, 2024

Conditions

PediatricCritical IllnessSleep Disturbance

Outcome Measures

Primary Outcomes (1)

  • Sleep Disturbances Scale for Children

    26-item parent report sleep measure; generates total T-score and 6 subscale T-scores (range 0-100, M 50, SD 10)

    1-month

Secondary Outcomes (1)

  • Pediatric Quality of Life Inventory Scale (PedsQL)

    1-month

Study Arms (2)

Before- standard care

NO INTERVENTION

After- intervention

OTHER

Patients studied in this arm receive the new educational intervention delivered in conjunction with standard care

Behavioral: Sleep education

Interventions

Sleep educationBEHAVIORAL

Participants receive a handout about age appropriate sleep goals and tips for improving sleep. The handout also contains links to educational videos about sleep hygiene and the importance of sleep to healing after illness. The handout is reviewed with a clinician at bedside prior to hospital discharge.

After- intervention

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 6 years to 18 years inclusive
  • Inpatient consult to Pediatric Critical Care and Neurotrauma Recovery Program

You may not qualify if:

  • Abusive trauma
  • Child protective services custody
  • Prisoners
  • Pregnancy
  • Non-English speaking caregivers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Critical IllnessParasomnias

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Cydni Williams, MD, MCR

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Before-after
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 18, 2023

First Posted

May 30, 2023

Study Start

April 18, 2022

Primary Completion

December 30, 2023

Study Completion

December 31, 2023

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)