Down Syndrome Obstructive Sleep Apnea
A legfontosabb adatok
- Hol
- Ann Arbor, Cincinnati, Cleveland, Los Angeles, Norfolk, Philadelphia és Seattle (Egyesült Államok)Mind a 7 helyszín megnézése
- Fázis
- 2. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 5 és 18 év között vagy?
Forrás: NCT06043440: ki vehet részt
Helyszínek itt: Egyesült Államok
- University of Michigan, Ann Arbor HospitalAnn Arbor, Egyesült ÁllamokContact: Emily HerreshoffRésztvevőt keres
- Cincinnati Children's Hospital Medical CenterCincinnati, Egyesült ÁllamokContact: Suzanna HicksRésztvevőt keres
- Rainbow Babies and Children's Hospital, Case Medical CenterCleveland, Egyesült ÁllamokContact: Alyssa KellerRésztvevőt keres
- Children's Hospital of Los AngelesLos Angeles, Egyesült ÁllamokContact: Danny Del Cid-LinareRésztvevőt keres
- East Virginia Medical CenterNorfolk, Egyesült ÁllamokContact: Thomas BoswickRésztvevőt keres
- Children's Hospital of PhiladelphiaPhiladelphia, Egyesült ÁllamokContact: Ebereh UwahRésztvevőt keres
- Seattle Children's HospitalSeattle, Egyesült ÁllamokContact: Sharon McNamaraRésztvevőt keres
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
- Brigham and Women's Hospital
- Azonosító
- NCT06043440
- A regiszteradat frissítve
- 2026. szeptember 30.
- Eredeti leírás
The purpose of this study is to assess whether oxygen supplementation during sleep improves working memory and other clinical and patient-reported outcomes among children who have Down Syndrome (DS) with moderate to severe Obstructive Sleep Apnea (OSA).A teljes eredeti leírásKevesebb
Randomized Control Trial of Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea
The purpose of this study is to assess whether oxygen supplementation during sleep improves working memory and other clinical and patient-reported outcomes among children who have Down Syndrome (DS) with moderate to severe Obstructive Sleep Apnea (OSA).
Bevonási feltételek: Ages 5.0 to 17.9 years at the time of screening; Children with OSA and obstructive apnea hypopnea index (OAHI) ≥5/hour; Absence of clinically significant hypoxia defined as oxygen saturation <88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen; Favorable response to oxygen therapy (allowing randomization) will be defined as follows:; Oxygen saturation nadir >92% and; Decrease in obstructive index < 5 / hour or by > 50% from screening PSG; Reaching an optimum oxygen flow which is defined as the flow that achieves the lowest level of AHI with maximum CO2 level less than 65 mmHg observed for 5 consecutive minutes and or an increase in CO2 by less than 15 points above baseline. The above criteria are observed while the patient spends a minimal of 30 minutes in the supine position and at least one cycle of rapid eye movement (REM) sleep; Oxygen flow required does not exceed 3.0 LPM and does not exceed a FiO2 > 40 %; Willingness to comply with all study procedures and available for duration of study; At baseline the participant attempts to perform the neuropsychological tests.
Kizáró feltételek: Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator; Individuals who develop alveolar hypoventilation with oxygen as previously defined; Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to the surgery; Unrepaired congenital heart disease; Other severe chronic diseases determined by their provider as making them poor study candidates; Current CPAP use with documented compliance(> 4 hrs/ night; > 70% of nights); Oxygen saturation < 90% at rest during wakefulness; Chronic daytime or nighttime use of supplemental oxygen; Smoker in the child's bedroom; Unable to participate in a PSG; Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial; Documented clinically significant untreated hypothyroidism.