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NCT04132999 · ClinicalTrials.gov registry record · NA
PAP for Children With DS and OSAS
A NA study of Obstructive Sleep Apnea and Down Syndrome, sponsored by University of Miami.
- Recruiting
- Registry status
- NA
- Development phase
- 86
- Enrollment target
- 3
- Study locations
NCT04132999: Recruiting NA study of Obstructive Sleep Apnea and Down Syndrome, sponsored by University of Miami.
NCT04132999 is a NA study of Obstructive Sleep Apnea and Down Syndrome that is actively recruiting participants, run by University of Miami. The registered enrollment target is 86 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (61% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04132999, a NA study of Obstructive Sleep Apnea and Down Syndrome, is actively recruiting participants, sponsored by University of Miami.
- RECRUITING
- Registry status
- NA
- Development phase
- 86 participants
- Enrollment target
- 3
- Study locations
Study Summary
Determine the efficacy of family-informed intervention (INT) vs standard clinical care over a period of twelve months in children with obstructive sleep apnea and Down Syndrome.
Primary Outcome
PAP adherence will be assessed as the percentage of nights in which the participant is adherent to PAP therapy from initiation (T0) through 6 months (T6). This is calculated as the number of nights meeting adherence criteria divided by the total number of nights during the participant's study participation period, multiplied by 100.
Conditions Studied
Interventions
- BEHAVIORAL Family-informed intervention
- BEHAVIORAL Standard Clinical Care
Study Locations (3)
Florida
- University of Miami - Miami
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2026-01-01 |
| Phase | NA |
What NCT04132999 shows while recruiting
NCT04132999 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (61% lower).
The record links to 2 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Family-informed intervention is the first listed.
NCT04132999 reports a single indexed study location in Florida, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04132999 about?
NCT04132999 is a clinical study titled "PAP for Children With DS and OSAS". Determine the efficacy of family-informed intervention (INT) vs standard clinical care over a period of twelve months in children with obstructive sleep apnea and Down Syndrome.
What is the current status of trial NCT04132999?
This trial is currently recruiting. It is a NA study. The enrollment target is 86 participants. The study started on 2021-03-01. Estimated completion is 2026-01-01.
What conditions does trial NCT04132999 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Down Syndrome.
What interventions are being tested in trial NCT04132999?
The interventions under investigation include: Family-informed intervention (BEHAVIORAL), Standard Clinical Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT04132999?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04132999 being conducted?
This trial has 3 study locations across Florida, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obstructive Sleep Apnea
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04132999's enrollment target sits among peer trials
86 75th of 155 higher than 81 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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