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Clinical trials for Sleep Disorder

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44341   clinical trials with a EudraCT protocol, of which   7370   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
    Study title: Sleep disordered breathing and daytime quality of life
    Active substance: BUDESONIDE
    Study summary document link (including results): Sleep disordered breathing and daytime quality of life in ch.pdf
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    Document reference: 47748
    Study title: Russo−R−M, Gururaj−V−J, Allen−J−E. The effectiveness of diphenhydramine HCI in pediatric sleep disorders. Journal of clinical pharmacology, {J−Clin−Pharmacol}, May−Jun 1976, vol. 16, no. 5−6, p. 284−8.
    Active substance: Dextromethorphan + Diphenhydramine + L-Menthol + Pseudoephedrine
    Study summary document link (including results):
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    Document reference: 25905
    Study title: Russo−R−M, Gururaj−V−J, Allen−J−E. The effectiveness of diphenhydramine HCI in pediatric sleep disorders. Journal of clinical pharmacology, {J−Clin−Pharmacol}, May−Jun 1976, vol. 16, no. 5−6, p. 284−8.Russo−R−M, Gururaj−V−J, Allen−J−E. The effectiveness of diphenhydramine HCI in pediatric sleep disorders. Journal of clinical pharmacology, {J−Clin−Pharmacol}, May−Jun 1976, vol. 16, no. 5−6, p. 284−8.
    Active substance: DIPHENHYDRAMINE AND GUAIFENESIN AND L-MENTHOL
    Study summary document link (including results):
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    Document reference: 26177
    Study title: Habre-Analgesic and respiratory effect of nalbuphine and pethidine for adenotonsillectomy in children with obstructive sleep disorder.
    Active substance: NALBUPHINE
    Study summary document link (including results):
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    Document reference: 32451
    Study title: Russo−R−M, Gururaj−V−J, Allen−J−E. The effectiveness of diphenhydramine HCI in pediatric sleep disorders. Journal of clinical pharmacology, {J−Clin−Pharmacol}, May−Jun 1976, vol. 16, no. 5−6, p. 284−8.
    Active substance: CODEINE_AND_DIPHENHYDRAMINE_AND_L-MENTHOL
    Study summary document link (including results):
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    Document reference: 24482
    Study title: Post-marketing surveillance study on the treatment of restlessness and nervous sleep disorder in children under 14 years of age (Euvegal® forte)
    Active substance: HERB: dry extract from Valerian root (3 - 6 : 1), extraction agent: ethanol 62 % (w/w); dry extract from Balm leaves (4 - 6 : 1), extraction agent: ethanol 30 % (w/w)./ HERB: dry extract from Valerian root (4 - 5 : 1), dry extract from Balm leaves (4 - 6 : 1)./ HERB: Extract of Valerian root, corresp. to 640-800 mg drug; + Extract of Melissa leaf, corresp. 60 320-480 mg drug./ HERB: dry extract...
    Study summary document link (including results):
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    Document reference: 21221
    Study title: Sleep disorders in Children. Observational study with a high dosage valerian extract.; Hintelmann C. Schweiz. Z. Ganzheitsmed. 2002;14( ): 404-407
    Active substance: (HERB) Valeriana officinalis L. extract
    Study summary document link (including results):
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    Document reference: 39724
    Study title: Reimão R, Lefévre AB.: Evaluation of flurazepam and placebo on sleep disorders in childhood. Arq Neuropsiquiatr. 1982 Mar;40(1):1-13.
    Active substance: FLURAZEPAM
    Study summary document link (including results):
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    Document reference: 28345
    Study title: VALUTAZIONE IN PEDIATRIA DELL'ATTIVITA' IPNOINDUCENTE DEL FLURAZEPAM GOCCE (VAL 779) Rapisarda V.; Germana B. Formazione Psichiatrica, December 1, 1980 , No. 4/- (181-190) Evaluation of flurazepam and placebo on sleep disorders in childhood. Reimão R, Lefévre AB. Arq Neuropsiquiatr. 1982 Mar;40(1):1-13.
    Active substance: FLURAZEPAM
    Study summary document link (including results):
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    Document reference: 28344
    Study title: "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." " "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." "
    Active substance: PRAZEPAM
    Study summary document link (including results):
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    Document reference: 34643
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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