Pediatric Down Syndrome Post-Approval Study
A legfontosabb adatok
- Hol
- Cleveland, Houston, Orange, Phoenix, Queens és Tampa (Egyesült Államok)Mind a 6 helyszín megnézése
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 13 és 18 év között vagy?
Forrás: NCT06851338: ki vehet részt
Helyszínek itt: Egyesült Államok
- Cleveland Clinic FoundationCleveland, Egyesült ÁllamokContact: Alex PiczerToborzás még nem indult
- Baylor College of Medicine/ Texas Children's HospitalHouston, Egyesült ÁllamokContact: Sadaf BatlaRésztvevőt keres
- Children's Hospital Orange CountyOrange, Egyesült ÁllamokContact: Eric RodriguezToborzás még nem indult
- Phoenix Children s HospitalPhoenix, Egyesült ÁllamokContact: Chase BeckermanToborzás még nem indult
- Northwell Cohen Children's HospitalQueens, Egyesült ÁllamokContact: Virginia MulloolyToborzás még nem indult
- University of South Florida, Morsani College of MedicineTampa, Egyesült ÁllamokContact: Alex CzachorToborzás még nem indult
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Inspire Medical Systems, Inc.
- Azonosító
- NCT06851338
- A regiszteradat frissítve
- 2025. február 28.
- Eredeti leírás
The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.A teljes eredeti leírásKevesebb
The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.
Bevonási feltételek: Patient has been diagnosed with Down syndrome; Patient is 13-18 years of age; Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of ≥ 10 and ≤ 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG); Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance; Patient is contraindicated for, or not effectively treated by, adenotonsillectomy; Treatment of patient's OSA has followed standard of care in considering all other alternative/adjunctive therapies; Patient, and their parents/guardians, is willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative in-lab sleep studies (PSGs), and questionnaire completion.
Kizáró feltételek: Patient has any condition or procedure that has compromised neurological control of the upper airway; Patient has a terminal illness with life expectancy of less than 12 months; Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas > 25% of the total apnea-hypopnea index (AHI); Patient has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate; Patient, or their parent/guardian, is unable or does not have the necessary assistance to operate the patient remote; Patient is pregnant or plans to become pregnant; Patient has an implantable device that may be susceptible to unintended interaction with the Inspire system; Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling; Any other reason the investigator deems the patient is unfit for participation in the study.