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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

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    Summary
    EudraCT Number:2015-003095-68
    Sponsor's Protocol Code Number:ORL-DISE-2015
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-04-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2015-003095-68
    A.3Full title of the trial
    Randomized cross-over open-label clinical trial to compare the videoendoscopic examination with induced sleep after sedation with propofol or clonidine
    Ensayo clínico aleatorizado cruzado y abierto para comparar la exploración videoendoscópica con sueño inducido (DISE) tras sedación con propofol o clonidina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized clinical trial to compare clonidine and propofol for the videoendoscopic examination with induced sleep
    Ensayo clínico randomizado para comparar clonidina y propofol para la exploración videoendoscopica con sueño inducido
    A.4.1Sponsor's protocol code numberORL-DISE-2015
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundació Parc Taulí
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFundació Parc Taulí
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari Parc Taulí
    B.5.2Functional name of contact pointOficina de Recerca
    B.5.3 Address:
    B.5.3.1Street AddressParc Taulí, 1
    B.5.3.2Town/ citySabadell
    B.5.3.3Post code08208
    B.5.3.4CountrySpain
    B.5.4Telephone number34937458451
    B.5.5Fax number34937175067
    B.5.6E-mailafarre@tauli.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameclonidine
    D.3.2Product code C02AC01
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLONIDINE
    D.3.9.1CAS number 4205-90-7
    D.3.9.4EV Substance CodeSUB06730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namepropofol
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpropofol
    D.3.9.3Other descriptive namePROPOFOL
    D.3.9.4EV Substance CodeSUB10116MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Apnea hypopnea syndrome
    El síndrome de apnea-hipopnea del sueño (SAHS)
    E.1.1.1Medical condition in easily understood language
    Sleep apnea syndrome
    El síndrome de apnea del sueño
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10040976
    E.1.2Term Sleep apnea syndrome
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the sleep pattern induced by clonidine and propofol in terms of proportion of patients who reach the N2 sleep phase without progressing to other phases during the examination
    ? Comparar los perfiles de sueño inducido por clonidina y propofol en cuanto a la proporción de pacientes que alcanzan fase de sueño N2 sin progresar a otras fases durante la exploración.
    E.2.2Secondary objectives of the trial
    To compare during the examination and by direct observation or blind evaluation:
    Site of upper airway collapse
    OAA/s (Observational sedation scale) and BIS (Bispectral Index)
    Correlation between BIS and EEG
    Duration and results of the examination
    ? Comparar intrapaciente durante la exploración, y mediante observación directa o evaluación ciega:
    o Lugar de colapso VAS
    o OAA/s (observational sedation scale) y BIS (bispectral index)
    o Correlación entre BIS y electroencefalograma.
    o Duración y resultados de la exploración.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients between 18 and 65 years old
    - Patients with ASA (American Society of Anesthesiologists) criteria I or II
    - Patients with Apnea-Hypopnea sleep syndrome of moderate or severe intensity, with no morbid obesity and who do not tolerate CPAP (continuous positive airway pressure)
    Patients with Apnea-Hypopnea syndrome in which the surgical treatment with mandibular advanced device is indicated
    - Patients with Apnea-hypopnea sleep syndrome who have not responded to surgical treatment
    - Informed consent
    ? Pacientes mayores de 18 años y menores de 65 años.
    ? Pacientes con criterios ASA (American Society of Anesthesiologists) I y II.
    ? Pacientes con SAHS (Síndrome de Apnea-Hipoapnea del sueño) moderado o severo sin obesidad mórbida, que no toleren CPAP (presión positiva continua en la vía aérea)
    ? Pacientes con SAHS leve o ronquido simple en los que esté indicado el tratamiento quirúrgico o con DAM (dispositivo Avance Mandibular).
    ? Pacientes SAHS que no hayan respondido al tratamiento quirúrgico.
    ? Consentimiento informado
    E.4Principal exclusion criteria
    Age < 18 or > 65 years old
    Alergic to propofol (ie soya bean or egg) or to clonidine
    High surgical risk (ASA III or higher)
    Severe cardiaack blockage (grade 2-3) without a pace maker
    Non controlled hypotension
    Severe cardiovascular disease
    ? Menores de 18 años
    ? Alergia a los componentes del propofol (especialmente soja o el huevo) o de la Clonidina.
    ? Riesgo quirúrgico elevado. (ASA mayor o igual a III)
    ? Bloqueo cardiaco avanzado (grado 2-3) en ausencia de marcapasos
    ? Hipotensión no controlada
    ? Enfermedad cardiovascular grave
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients that reach sleep phase N2 without progressing to deeper sleep phases, assessed by means of hypnogram
    Proporción de pacientes que alcanzan fase de sueño N2 sin progresar a fases de sueño más profundas, evaluado mediante hipnograma
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the endoscopic examination
    Durante la exploración endoscópica
    E.5.2Secondary end point(s)
    Mean oxigen saturation
    BP (Systolic and Dyastolic)
    Degree of baseline subjective somnolence
    Degree of reproducibility of the examination
    Examination of the upper airway collapse areas
    Characteristics of the snore
    Duration of the examination (in minutes)
    Maniouvres that modify the snore/apnea
    ? Grado de profundidad anestésica o de consciencia
    ? Tiempo de saturación inferior al 90%
    ? Índice de desaturación del 3%
    ? Índice de apnea-hipopnea
    ? Porcentaje de fases de sueño
    ? Frecuencia cardiaca
    ? Saturación media de oxígeno
    ? TA (sistólica y diastólica)
    ? Grado de somnolencia basal subjetiva
    ? Grado de reproducibilidad de la exploración
    ? Exploración de las áreas de colapso de VAS (via área superior)
    ? Características del ronquido
    ? Tiempo duración de la exploración (min.)
    ? Maniobras que modifican el ronquido/apnea
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the endoscopic examination
    Durante la exploración endoscópica
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Evaluación ciega por terceros
    Third party blind evaluation
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Las patient last assessment
    Ultimo paciente, última evaluación
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    non applicable
    No aplica
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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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
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