RecruitingNot a traditional drug phaseobservationalRules rewrite

Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea

Q: Is NCT05052216 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT05052216?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT05052216?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

Background: Obstructive sleep apnea (OSA) occurs when the blockage of the airway causes a person to stop breathing involuntarily for 10 seconds or more throughout the night during sleep. Pediatric OSA can be especially concerning and can have long-term effects.

Official registry: https://clinicaltrials.gov/study/NCT05052216 · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · enrollment listed as 120

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 120 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea

Primary outcome (registry wording): ScO2, StO2

Who it is for (from inclusion criteria)

Ages 3 Years to 12 Years
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Male or female, aged \>=3 and \<13 years
For NORM group: Children without OSA (AHI\<2)
For OSA group: Children with OSA (AHI\>=2)

Who the registry excludes

An individual who meets any of the following criteria will be excluded from participation in this study:
Children \<3 years or \>=13 years
Any chronic or acute medical condition that in the opinion of the investigators will interfere with overnight sleep study acquisition
Any head injuries or physical conditions that in the opinion of the investigators would affect probe signal and contact
For NORM group: Children with AHI\>=2
For OSA group: Children with AHI\<2

Public study contact (from the registry)

Thien T Nguyen

(301) 814-7234

thien.nguyen4@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

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FAQ about this NCT record

Is NCT05052216 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05052216?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05052216?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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