- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00691080
Forstå søvnproblemer hos børn med autismespektrumforstyrrelse (REST)
Karakterisering af endogene melatoninprofiler hos børn med autismespektrumforstyrrelse.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Dette er et forslag til undersøgelse af forholdet mellem melatonin (MT) og søvnproblemer hos børn med autismespektrumforstyrrelse (ASD), som en del af den kollaborative forskningsstruktur i Autism Treatment Network (ATN). Et hovedmål med ATN er at udføre klinisk forskning, der vil have en betydelig indvirkning på dagligdagen og funktionsmåden for personer med ASD og at imødekomme forældrenes umiddelbare bekymringer. Børn med ASD oplever høje forekomster af søvnforstyrrelser, hvilket sandsynligvis bidrager til sværhedsgraden af deres kognitive og adfærdsmæssige dysfunktion i dagtimerne og til dårligere livskvalitet for dem og deres familier.
Som et skridt i retning af at adressere søvnproblemer ved ASD, foreslår vi at teste hypotesen om, at børn med ASD og søvnproblemer vil have en forsinkelse i MT-debut og/eller have nedsat MT-sekretion over 24 timer sammenlignet med normale kontroller.
Primært endepunkt: Karakteriser de endogene MT-profiler hos børn med ASD:
Vi forudsiger, at resultater fra denne undersøgelse vil afsløre lavere niveauer af metaboliseret MT hos børn med ASD sammenlignet med normale børn. Derudover forudser vi, at børn med ASD vil have forsinket MT-debut eller ændret cirkadisk fase.
Data fra denne undersøgelse vil give vigtig information vedrørende dysregulering af døgnrytme i ASD og vil understøtte udviklingen af fremtidige undersøgelser, der bruger MT til at modificere og korrigere unormale døgnrytmer.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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New York
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New York, New York, Forenede Stater, 10032
- Columbia University
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health & Sciences University
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Texas
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
- Diagnose af autismespektrumforstyrrelse; understøttet af ADOS og ADI eller SCQ (fag).
- Alder større end eller lig med 4 eller mindre end eller lig med 9 år;
- Forældre har givet informeret samtykke.
- Forældre/plejer behersker engelsk flydende skriftligt og mundtligt.
- Kun kontroller: En SCQ-score på mindre end 10 uden forældrenes eller lægens bekymring for en anden neuro-udviklingsforstyrrelse vil blive brugt til at definere normale børn.
Ekskluderingskriterier:
- Nuværende brug af psykoaktive lægemidler (f. fluoxetin, methylphenidat, risperidon, lithium, etc.)*;
- Aktuel eller brug inden for den sidste 1 måned af betablokkere eller melatonin;
- Nuværende brug af søvnmidler;
- Tilstedeværelse af ubehandlede medicinske problemer, der ellers kunne forklare søvnproblemer (f. obstruktiv søvnapnø, gastroøsofageal reflukssygdom - GERD);
- Blindhed.
Kun kontroller: nuværende eller tidligere diagnose af ADHD, depression, angst eller andre psykiatriske tilstande. (7) Kun kontroller: Søskende har diagnosen autismespektrumforstyrrelse.
- Psykoaktiv medicin kan seponeres, men forældrene skal drøfte seponering af medicin med deres ordinerende læge, før de reducerer eller stopper medicinen.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Tværsnit
Kohorter og interventioner
Gruppe / kohorte |
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ASD børn
ASD børn som defineret af:
(6) Ingen blindhed. |
"Raske" kontrolbørn
"Raske" kontrolbørn som defineret af:
(6) Ingen blindhed. (7) Ingen nuværende eller tidligere diagnose af ADHD, depression, angst eller andre psykiatriske tilstande. (8) Ingen søskende med diagnosen autismespektrumforstyrrelse. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Søvnforsinkelse, målt ved aktigrafi
Tidsramme: En uge
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En uge
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Samlet søvntid, målt ved aktigrafi
Tidsramme: En uge
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En uge
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Daniel G Glaze, M.D., Baylor College of Medicine
Publikationer og nyttige links
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- Mindell JA, Emslie G, Blumer J, Genel M, Glaze D, Ivanenko A, Johnson K, Rosen C, Steinberg F, Roth T, Banas B. Pharmacologic management of insomnia in children and adolescents: consensus statement. Pediatrics. 2006 Jun;117(6):e1223-32. doi: 10.1542/peds.2005-1693.
- Dahl RE. The impact of inadequate sleep on children's daytime cognitive function. Semin Pediatr Neurol. 1996 Mar;3(1):44-50. doi: 10.1016/s1071-9091(96)80028-3.
- Beebe DW, Wells CT, Jeffries J, Chini B, Kalra M, Amin R. Neuropsychological effects of pediatric obstructive sleep apnea. J Int Neuropsychol Soc. 2004 Nov;10(7):962-75. doi: 10.1017/s135561770410708x.
- O'Brien LM, Gozal D. Neurocognitive dysfunction and sleep in children: from human to rodent. Pediatr Clin North Am. 2004 Feb;51(1):187-202. doi: 10.1016/s0031-3955(03)00184-6.
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- Nir I, Meir D, Zilber N, Knobler H, Hadjez J, Lerner Y. Brief report: circadian melatonin, thyroid-stimulating hormone, prolactin, and cortisol levels in serum of young adults with autism. J Autism Dev Disord. 1995 Dec;25(6):641-54. doi: 10.1007/BF02178193.
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Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2003
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