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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 279 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Eligibility criteria shortened, about 11 words
  3. 16 versions Re-verified since Jan 6, 2026, no change to tracked fieldsv262-v277
  4. Primary and study completion dates: Jan 31, 2027 to Jan 31, 2028v261
  5. 5 versions Re-verified since Mar 6, 2025, no change to tracked fieldsv256-v260
Show 26 earlier versionsHide 26 earlier versions
  1. Primary and study completion dates: Jan 31, 2026 to Jan 31, 2027v255
  2. Enrollment target: 70 to 120v254
  3. 10 versions Re-verified since Nov 15, 2023, no change to tracked fieldsv244-v253
  4. Enrollment target: 47 to 70
    • Eligibility criteria shortened, about 10 words
    v243
  5. Eligibility criteria shortened, about 1 wordv242
  6. 4 versions Re-verified since Mar 7, 2023, no change to tracked fieldsv238-v241
  7. Eligibility criteria revisedv237
  8. 2 versions Re-verified since Oct 11, 2022, no change to tracked fieldsv235-v236
  9. Study Status, Eligibilityv234
  10. Re-verified, no change to tracked fieldsv233
  11. Study Status, Study Description, Outcome Measuresv232
  12. Start date changed from estimate of Aug 31, 2022 to Aug 25, 2022v231
  13. Start date: Aug 30, 2022 to Aug 31, 2022v230
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. Researchers want to see how a monitoring device called near-infrared spectroscopy (NIRS) compares with the traditional techniques used in children s sleep studies. Objective: To learn about oxygen levels in the brain and limbs in children with and without sleep apnea using a wearable, point-of-care biosensor. Eligibility: Children aged 3-12 who have OSA and plan to receive treatment (OSA group) or who do not have OSA (NORM group). Design: Participants will be screened with a review of their medical records. If they have taken part in other NIH studies, that data will be reviewed as well. Participants in the NORM group will have 1 overnight study visit. Those in the OSA group will have 2 overnight study visits. Participants will do an overnight sleep study. They will have a physical exam and medical history. They will have a sleep study electroencephalography (EEG). For this, electrodes will be placed on their head. They will wear a gauze cap to keep the electrodes in place. Two NIRS probes made of a soft silicon will be placed on their forehead and arm. They will follow their normal bedtime routine. Their parent will stay overnight. The OSA group will have a second study visit 2 weeks to 12 months after they start treatment for their sleep apnea. They will repeat the sleep study.
Trial Details
NCT Number NCT05052216
Lead Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Pediatric Obstructive Sleep Apnea
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov