Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Sleep disorders and disturbances

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   44412   clinical trials with a EudraCT protocol, of which   7421   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.
    Advanced Search: Search tools
     
    62 result(s) found for: Sleep disorders and disturbances. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2006-005103-33 Sponsor Protocol Number: WEL-SOM01-2006/01 Start Date*: 2007-01-26
    Sponsor Name:Laboratoires WELEDA
    Full Title: Study of sleep characteristics and parameters in patients suffering from minors sleep disorders treated by the homeopathic medicinal product Somnidoron®, oral drops, solution.
    Medical condition: Minors sleep disorders
    Disease: Version SOC Term Classification Code Term Level
    8.1 10040984 Sleep disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005719-89 Sponsor Protocol Number: 12440 / R-0631M / Melody Start Date*: 2007-01-04
    Sponsor Name:Meander Medical Center
    Full Title: Double blind placebo controlled study on the efficacy of melatonin on sleep parameters and quality of life in hemodialysis patients
    Medical condition: Sleep problems in hemodialysis patients
    Disease: Version SOC Term Classification Code Term Level
    8.1 10040991 Sleep disorders and disturbances HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-004640-78 Sponsor Protocol Number: ITI-007-004 Start Date*: 2007-11-13
    Sponsor Name:Intra-Cellular Therapies, Inc
    Full Title: A randomized, double-blind, placebo-controlled, 4-way crossover study of ITI-007 in subjects with sleep maintenance insomnia
    Medical condition: Sleep maintenance disorders
    Disease: Version SOC Term Classification Code Term Level
    9.1 10040984 Sleep disorder LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-002875-15 Sponsor Protocol Number: TAK-375_107 Start Date*: 2007-12-11
    Sponsor Name:Takeda
    Full Title: A Single-Center, Randomized, Double-Blind, Double-Dummy Placebo Controlled, Cross-Over Study to Investigate the Next Morning Effects of Ramelteon (8mg), Zopiclone (7.5mg) and Placebo on Actual Driv...
    Medical condition: insomnia characterised by difficulty with sleep onset
    Disease: Version SOC Term Classification Code Term Level
    10.0 10040984 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-004644-35 Sponsor Protocol Number: PKD10491 Start Date*: 2015-03-17
    Sponsor Name:Sanofi-aventis
    Full Title: Single dose, open label safety, tolerability, pharmacokinetic and pharmacodynamic evaluation of three different eplivanserin doses in children aged 6-17 years with insomnia of various origins
    Medical condition: Sleep Initiation and Maintenance Disorders
    Disease: Version SOC Term Classification Code Term Level
    17.1 10037175 - Psychiatric disorders 10040984 Sleep disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-022460-12 Sponsor Protocol Number: MVH-03 Start Date*: 2011-03-23
    Sponsor Name:Herlev Hospital
    Full Title: The effect of melatonin on depression, anxiety, cogntive function and sleep disturbances in breast cancer patients
    Medical condition: Depression Anxiety Postoperative cognitive dysfunction Sleep disturbances
    Disease: Version SOC Term Classification Code Term Level
    12.1 10012378 Depression LLT
    12.1 10002855 Anxiety LLT
    12.1 10009845 Cognitive disturbance LLT
    12.1 10040997 Sleep disturbances LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-002213-21 Sponsor Protocol Number: VP-VEC-162-2102 Start Date*: 2016-08-15
    Sponsor Name:Vanda Pharmaceuticals Inc
    Full Title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL PROOF OF CONCEPT STUDY TO EVALUATE THE EFFECTS OF MULTIPLE ORAL DOSES OF TASIMELTEON AND MATCHING PLACEBO IN TRAVELERS WITH JET...
    Medical condition: Jet Lag Disorder (JLD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10040984 Sleep disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-003198-14 Sponsor Protocol Number: VP-VEC-162-3106 Start Date*: 2015-12-21
    Sponsor Name:Vanda Pharmaceuticals Inc
    Full Title: A multicenter, randomized, double-blind, placebo-controlled, parallel study to investigate the efficacy and safety of multiple oral doses of tasimelteon and matching placebo in travelers with Jet L...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.1 10037175 - Psychiatric disorders 10040984 Sleep disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-004025-28 Sponsor Protocol Number: HTA 05-14-02 Start Date*: 2007-06-26
    Sponsor Name:Royal Liverpool Children’s NHS Trust
    Full Title: MENDS: The use of MElatonin in children with Neuro-developmental Disorders and impaired Sleep; a randomised, double-blind, placebo-controlled, parallel study
    Medical condition: children with neuro-developmental disorders and impaired sleep
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064062 Neurodevelopmental disorder PT
    9.1 10040984 Sleep disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-003975-35 Sponsor Protocol Number: 750201.01.014 Start Date*: 2005-05-18
    Sponsor Name:Dr. Willmar Schwabe GmbH & Co. KG
    Full Title: Multi-center, double-blind, placebo-controlled, randomized phase III study to prove the efficacy, safety and tolerability of Lavender oil WS 1265 (Lavandula angustifolia) in patients with restlessn...
    Medical condition: restlessness and sleep disturbances MedDRA Code for RESTLESSNESS: 10038743 MedDRA Code für SLEEP DISTURBANCES: 10040997
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-003394-15 Sponsor Protocol Number: VP-VEC-162-4201 Start Date*: 2016-06-28
    Sponsor Name:Vanda Pharmaceuitcals Inc.
    Full Title: OPEN-LABEL STUDY TO INVESTIGATE THE PHARMACOKINETICS AND SAFETY OF TASIMELTEON IN TOTALLY BLIND CHILDREN AND ADOLESCENTS WITH NON-24-HOUR SLEEP- WAKE DISORDER
    Medical condition: This study will be an open-label, single dose, non-controlled trial to evaluate the pharmacokinetics and safety of tasimelteon in children who are 3 years to less than 18 years of age, totally blin...
    Disease: Version SOC Term Classification Code Term Level
    19.0 10037175 - Psychiatric disorders 10040984 Sleep disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-005475-40 Sponsor Protocol Number: VP-VEC-162-3502 Start Date*: 2022-06-08
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: A multicenter, double-blind, randomized study to evaluate the effects of tasimelteon vs. placebo in participants with Delayed Sleep-Wake Phase Disorder (DSWPD)
    Medical condition: Delayed Sleep-Wake Phase Disorder (DSWPD)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029205 - Nervous system disorders 10041013 Sleep-wake schedule disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002189-39 Sponsor Protocol Number: 161802 Start Date*: 2017-12-11
    Sponsor Name:University of Oxford
    Full Title: A randomised placebo-controlled trial to assess the effect of melatonin on circadian sleep-wake disturbances in ocular disease.
    Medical condition: circadian sleep-wake disturbances associated with ocular disease.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10009191 Circadian rhythm sleep disorder PT
    21.1 10029205 - Nervous system disorders 10009191 Circadian rhythm sleep disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-001311-79 Sponsor Protocol Number: JZP080-301 Start Date*: 2019-01-09
    Sponsor Name:Jazz Pharmaceuticals
    Full Title: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) with an Open-label Safety Extension
    Medical condition: Treatment of Idiopathic Hypersomnia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10040989 Sleep disorder NOS LLT
    20.1 100000004852 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (GB - no longer in EU/EEA) CZ (Completed) BE (Completed) DE (Completed) ES (Completed) FI (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-002505-74 Sponsor Protocol Number: CEP1538/3034/ES/MN Start Date*: 2005-01-05
    Sponsor Name:Cephalon Europe, A Division of Cephalon UK Limited
    Full Title: A 6 month open-label, flexible-dosage study to assess the safety and effectiveness of PROVIGIL® (Modafinil) treatment in children and adolescents with excessive sleepiness associated with narcoleps...
    Medical condition: Excessive sleepiness associated with Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome.
    Disease: Version SOC Term Classification Code Term Level
    7.0 10015595 LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) FI (Completed) GB (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-001230-17 Sponsor Protocol Number: 2012.732 Start Date*: 2013-08-14
    Sponsor Name:Hospices Civils de Lyon
    Full Title: La mélatonine restaure-t-elle l’architecture du sommeil chez les enfants avec autisme ? Etude de phase II.
    Medical condition: Autisme infantile Troubles du sommeil
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004852 10021737 Infantile autism LLT
    18.0 10037175 - Psychiatric disorders 10040991 Sleep disorders and disturbances HLGT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-005194-56 Sponsor Protocol Number: AC-057A301 Start Date*: 2008-07-06
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Multi center, double blind, randomized, placebo controlled, active reference, parallel group polysomnography study to assess the efficacy and safety of a 16 day oral administration of ACT 078573 in...
    Medical condition: Chronic primary insomnia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10022437 Insomnia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) SE (Completed) AT (Completed) HU (Completed) SK (Completed) DE (Completed) FI (Completed) ES (Completed) CZ (Completed) FR (Completed) DK (Completed) GB (Completed) IT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2017-003766-27 Sponsor Protocol Number: 848015011 Start Date*: 2018-07-18
    Sponsor Name:VU University Medical Centre
    Full Title: The DREAMING study: Efficacy of low dose amitriptyline and mirtazapine for insomnia disorder: a double-blind, randomized, placebo-controlled trial in general practice
    Medical condition: Insonnia disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10078083 Insomnia disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-023756-82 Sponsor Protocol Number: TUD-RaSPar-051 Start Date*: 2011-07-13
    Sponsor Name:Dresden University of Technology
    Full Title: Rasagiline treatment for Sleep disorders in Parkinson´s disease
    Medical condition: sleep disturbances/sleep disorders in patients with Parkinson´s disease
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029205 - Nervous system disorders 10013113 Disease Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-005303-34 Sponsor Protocol Number: EFC6072 Start Date*: 2007-06-01
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: Efficacy and safety of 2 mg/day M100907 on Sleep Maintenance Insomnia: a 6-week, multicenter, randomized, double-blind, placebo-controlled Polysomnographic study
    Medical condition: Sleep maintenance insomnia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) AT (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  4  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Oct 16 08:36:46 CEST 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA