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NCT03922165: HELP-DS
Healthy Sleep for Children With Down Syndrome
trial testing Adenotonsillectomy in Down Syndrome in 26 participants. Completed in 31 December 2021.
20 December 2021
Quick facts
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 26 |
| Start date | 22 May 2019 |
| Primary completion | 20 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Adenotonsillectomy
Conditions studied
- Down Syndrome — all drugs for Down Syndrome →
- Sleep Disordered Breathing — all drugs for Sleep Disordered Breathing →
Sponsor
Brigham and Women's Hospital
Who can join
Adults 3 to 13, any sex, with Down Syndrome or Sleep Disordered Breathing. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this multi-center observational study (utilizing the sites enrolling patients for the Pediatric Adenotonsillectomy Trial for Snoring (PATS) \[1U011HL125307-O1A1\]) is to gather data regarding children with Down syndrome (DS) and Sleep Disordered Breathing (SDB) referred for treatment with adenotonsillectomy to inform a future randomized controlled trial in this population.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03922165
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Adenotonsillectomy
Trials testing the same drug.
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- NCT06917768 — Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea · NA · completed
- NCT05368077 — Brain Changes in Pediatric OSA · NA · completed
Other recruiting trials for Down Syndrome
Currently open trials in the same condition.
- NCT07416201 — Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy · recruiting
- NCT07484464 — Effects of the Otago Exercise Program on Balance, Endurance, and Motor Coordination in Children With Down Syndrome · NA · recruiting
- NCT07428863 — Effects of Jump Rope on Navicular Drop in Down Syndrome · NA · recruiting
- NCT07260136 — Cervical Spine Abnormalities in Down Syndrome · active not recruiting
- NCT07248449 — Physical Fitness in DS: A Comparison of Cuevas Medak and Rebound Exercises · NA · recruiting
Other Brigham and Women's Hospital trials
Trials by the same sponsor.
- NCT07011758 — Dynamic Treatment Regimes for Opioid Use Disorder · Phase 2 · not yet recruiting
- NCT06310018 — Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE · suspended
- NCT04519177 — Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ... · NA · not yet recruiting
- NCT06355986 — Computerized Decision Support to Prevent Stroke in Atrial Fibrillation · NA · not yet recruiting
- NCT06099275 — Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03922165 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Brigham and Women's Hospital
- Last refreshed: 2 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03922165.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing