NCT02132273

Brief Summary

The investigators hypothesize that use of an educational story with pictures illustrating overnight sleep study procedure (also called polysomnography or PSG)accompanied by simple narrative will be a cost-effective, readily accepted intervention that will contribute to successful completion of sleep studies among children with disabilities. Children who have been referred for a clinical sleep study at Kennedy Krieger Institute (KKI) will be enrolled and randomized to either recieve usual care (discussion of polysomnography with referring clinicians) or educational story intervention. Both groups of participants will be asked to complete questionnaries before and after the sleep study. Set-up for the sleep study will be videotaped so that behavior of the child can be evaluated. The investigators will evaluate whether successful study completion differs between the two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

2.2 years

First QC Date

May 5, 2014

Last Update Submit

September 23, 2016

Conditions

Developmental DisabilitiesSleep DisordersPolysomnographyPreparation for Medical ProcedureChild

Outcome Measures

Primary Outcomes (1)

  • Task Analysis and Pediatric Behavior Adjustment Scale

    Task Analysis: Quantification of number of PSG steps technician was able to complete during setup Pediatric Behavior Adjustment Scale: Quantification of child escape behaviors during PSG equipment setup based on standardized review of audio and video recording

    PSG Set-UP 2- 3 weeks after enrollment

Secondary Outcomes (1)

  • Parent Completed Questionnaires

    2-3 weeks prior to PSG, and night of Sleep Study

Other Outcomes (1)

  • Educational Story Questionnaire

    Morning after PSG (Treatment Group Only) 3-4 weeks after enrollment.

Study Arms (2)

Educational Story

EXPERIMENTAL

Participants receiving this intervention will have access to the educational story as they prepare for the overnight sleep study.

Other: Educational Story

Typical Preparation

NO INTERVENTION

Participants will receive traditional materials, directions, what to bring list, only. They will not recieve access to educational story

Interventions

Educational StoryOTHER

Educational story with pictures illustrating overnight polysomnography procedure accompanied by simple narrative.

Also known as: "The Sleep Study Story"
Educational Story

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical recommendation for polysomnography to be performed at KKI Clinical Neurophysiology Laboratory
  • age 4 -17 years
  • adequate health to tolerate procedure without additional nursing care
  • English speaking caregiver, over 18 years of age
  • Caregiver must have full guardianship of child participant
  • Caregiver must be able to complete written questionnaires and read the educational story to their child
  • Caregiver must be able to accompany child participant to the sleep study

You may not qualify if:

  • non-english speaking children
  • children in foster care or wards of the state
  • child with absence of developmental disability
  • child with presence of severe-profound intellectual disability
  • child with severe disruptive or aggressive behaviors
  • recommended for titration study (CPAP and/or supplemental oxygen)
  • children requiring behavioral desensitization prior to sleep study.
  • Caregivers that are non-English Speaking
  • Caregivers that are under 18 years of age
  • foster parents or temporary guardians
  • cargivers with inability to reach educational story and/or complete questionnaires.
  • caregiver is unable to accompany the child to the sleep study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Developmental DisabilitiesSleep Wake Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Accardo, MD

    Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 7, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)