Home sleep apnea test for Sleep Apnea Syndromes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Children's Hospital of Philadelphia, Philadelphia, PA
Sleep Apnea Syndromes+7 More
Home sleep apnea test - DiagnosticTest
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

This clinical trial will compare home sleep apnea testing with the gold standard in-lab polysomnography in terms of 1) accuracy, 2) therapeutic decision-making, and 3) parent/child acceptability in children referred for evaluation of obstructive sleep apnea.

Eligible Conditions

  • Sleep Apnea Syndromes
  • Sleep Disturbance
  • Sleep disorders and disturbances
  • Sleep Apnea, Obstructive

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Sleep Apnea Syndromes

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 2 weeks

2 weeks
Association between therapeutic decision from HSAT compared to PSG
Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG
Proportion of participants who prefer HSAT to PSG
Proportion of participants with diagnosis of OSA on both HSAT and PSG

Trial Safety

Safety Progress

1 of 3

Other trials for Sleep Apnea Syndromes

Trial Design

2 Treatment Groups

PSG first
1 of 2
HSAT first
1 of 2
Active Control
Experimental Treatment

317 Total Participants · 2 Treatment Groups

Primary Treatment: Home sleep apnea test · No Placebo Group · N/A

HSAT first
DiagnosticTest
Experimental Group · 1 Intervention: Home sleep apnea test · Intervention Types: DiagnosticTest
PSG first
DiagnosticTest
ActiveComparator Group · 1 Intervention: In-lab polysomnography · Intervention Types: DiagnosticTest

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks
Closest Location: The Children's Hospital of Philadelphia · Philadelphia, PA
Photo of Philadelphia 1Photo of Philadelphia 2Photo of Philadelphia 3
2005First Recorded Clinical Trial
4 TrialsResearching Sleep Apnea Syndromes
207 CompletedClinical Trials

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,390 Previous Clinical Trials
24,521,240 Total Patients Enrolled
28 Trials studying Sleep Apnea Syndromes
3,054 Patients Enrolled for Sleep Apnea Syndromes
Children's Hospital of PhiladelphiaLead Sponsor
640 Previous Clinical Trials
7,846,652 Total Patients Enrolled
11 Trials studying Sleep Apnea Syndromes
1,502 Patients Enrolled for Sleep Apnea Syndromes
Christopher M Cielo, DOPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Sleep Apnea Syndromes
60 Patients Enrolled for Sleep Apnea Syndromes

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a male or female child between the ages of 5 and 12 years old.
Parental/guardian permission (informed consent) and if appropriate, child assent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References