An observational study in Pediatric Obstructive Sleep Apnea, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Recruiting at 1 site in United States. Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Observational
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Among 753 studies in Sleep Apnea, Obstructive with a site in United States — 126 open to participants now, 160 under way, 9 of them phase 3. Sleep Apnea, Obstructive · United States.
Among the 753 studies in Sleep Apnea, Obstructive with a site in United States, this one is the 56th largest by planned enrollment of the 157 observational ones that give a count, is one of 40 that started in 2022, is one of 157 observational ones, reaches primary completion later than 122 of the 159 other live ones, and was the 551st registered.
2,243 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
Browse Sleep Apnea, Obstructive studies →126 of the 753 studies in Sleep Apnea, Obstructive with a site in United States are open now. Recruiting first, the newest first:
Pfizer · Sites in United States
Ages 18+
Nevada Dental Sleep · Sites in United States
Ages 18+
University of Chicago · Sites in United States
Ages 18–40 · Women only
Fisher and Paykel Healthcare · Sites in United States
Ages 22+
Brigham and Women's Hospital · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 313 Sleep Apnea, Obstructive studies recruiting now, 146 (47%) set no upper age limit and 124 (40%) stop at 75 or younger; 52 take children under 18; 65 take healthy volunteers.
This study: 3 Years to 12 Years · all sexes · healthy volunteers too.
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753 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 52 · Phase 2 85 · Phase 3 45 · Phase 4 36
First in 1999; this study’s year is marked. 40 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is above the median of 105 across 667 observational studies indexed under Sleep Apnea, Obstructive.
Median enrollment 49 across the 594 interventional studies, 81 across the 157 observational. Of the 512 that completed or were terminated, 257 (50%) have results posted.
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192 of 753 have an industry lead sponsor. The 10 most frequent:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 422 studies on the registry; 24 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has 1 study filed under Sleep Apnea, Obstructive — fewer than ten, so there is no comparison to draw.
65 of the studies in Sleep Apnea, Obstructive with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07225686Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy | 2027-08-20 |
| NCT07226765Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy | 2027-08-30 |
| NCT04814420Tulane UniversityAtrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study | 2026-11 |
| NCT07103941Isabel Moreno HayIOA Preventing Occlusal Changes With MAD Use | 2026-11-28 |
| NCT01857427Ulysses Magalang MDA Prospective Observational Cohort to Study the Genetics of Obstructive Sleep Apnea and Associated Co-Morbidities | 2026-12 |
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Among the 753 studies in Sleep Apnea, Obstructive with a site in United States, from their registry updates:
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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.
Study Description:
This observational study will assess the sensitivity of near-infrared spectroscopy (NIRS) to hemodynamic events caused by pediatric obstructive sleep apnea (POSA). NIRS can provide a direct examination of brain oxygen saturation that traditional sleep study measurements are not able to capture and may be capable of better explaining health outcomes related to this disease. The purpose of this study is to characterize a wearable, point-of-care NIRS device that measures multiple physiological signals with a focus on cerebral and peripheral oxygenation in children with obstructive sleep apnea and to establish the relationship between traditionally measured parameters during sleep studies (polysomnography) and NIRS technologies. This study will be conducted in collaboration with the Sleep and Neurodevelopment Service at the NIH Clinical Center. Care will not be altered for any patients and this study will be purely observational with no significant risk added to any patient. We hypothesize that changes in NIRS signals of cerebral and peripheral tissue oxygenation due to apnea events will correlate with respiratory flow and oxygen saturation changes measured with PSG.
Objectives:
Primary Objective: Characterize cerebral oxygen saturation and peripheral tissue oxygen saturation during both normal sleep and sleep apnea events in children with respect to traditional polysomnography parameters.
Exploratory Objective 1: Characterize cerebral and peripheral tissue oxygen saturation before and after POSA treatment with respect to traditional polysomnography parameters.
Exploratory Objective 2: Characterize the dynamics of hemoglobin concentrations and tissue oxygenation during different sleep stages.
Exploratory Objective 3: Compare dynamics of cerebral and peripheral tissue oxygen saturation during apneic events in sleep state to a breath hold while subject is awake.
Endpoints:
Primary Endpoint: cerebral oxygen saturation (ScO2), peripheral tissue oxygen saturation (StO2), pulsatile oxygen saturation (SpO2), respiratory flow
Exploratory Endpoint 1: baseline and post-treatment ScO2, StO2, SpO2, AHI, respiratory flow
Exploratory Endpoint 2: baseline and post-treatment delta hemoglobin, delta deoxyhemoglobin, cerebral oxygen saturation
Exploratory Endpoint 3: ScO2, StO2 (during apnea and breath hold)
subjects enrolled in other sleep studies, subjects set to receive OSA treatment in the local area
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
healthy children
children with obstructive sleep apnea
ScO2, StO2
peripheral tissue oxygen saturation (StO2), traditional polysomnography measures (SpO2, respiratory effort)
Time frame: Baseline
Plan to share: No — Not a clinical trial. This study serves as a pilot to evaluate and characterize a portable NIRS device for sleep research.
Started Aug 2022 (actual). Primary completion is estimated for Jan 2028, 65 months after the start.
Of 258 non-industry observational studies under Sleep Apnea, Obstructive, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 61. This study's planned 65 months is above that.
Counting every sponsor, half of 294 studies reached it within 28 months; a quarter within 14 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) →