Clinical Trials Register

Summary
EudraCT Number:	2011-002279-40
Sponsor's Protocol Code Number:	OSAS_2011
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2011-10-24
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

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2011-002279-40

A.3

Full title of the trial

Comparative study of the hypnosedative management during video sleep endoscopy in patients with obstructive sleep apnoe syndrome

Vergleichende Untersuchung für hypnosedatives Management im Rahmen der Schlafvideoendoskopie bei Patienten mit obstruktiven Schlafapnoesyndrom

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Comparative study of the hypnosedative management (=inducing a sleep-like condition) during video sleep endoscopy (= examination of the nose and the throat with a camera) in patients with obstructive sleep apnoe syndrome (= one or more pauses in breathing or shallow breaths while sleeping)

Vergleichende Untersuchung für hypnosedatives Management (= Hervorrufen eines schlafähnlichen Zustandes) im Rahmen der Schlafvideoendoskopie (=Begutachtung der Nasengänge, des Rachens, des oberen Kehlkopfbereiches und der Stimmritze mit einer kleinen flexiblen Kamera) bei Patienten mit obstruktiven Schlafapnoesyndrom (

A.3.2

Name or abbreviated title of the trial where available

OSAS_2011

A.4.1

Sponsor's protocol code number

OSAS_2011

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Med Uni Graz, Abt. für NEURO- u. GESICHTSCHIRURGISCHE ANÄSTHESIE u. INTENSIVMEDIZIN
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Med Uni Graz, Abt. für NEURO- u. GESICHTSCHIRURGISCHE ANÄSTHESIE u. INTENSIVMEDIZIN
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Med Uni Graz, Abt. für NEURO- u. GESICHTSCHIRURGISCHE ANÄSTHESIE u. INTENSIVMEDIZIN
B.5.2	Functional name of contact point	Auskunft
B.5.3	Address:
B.5.3.1	Street Address	Auenbruggerplatz 29/I
B.5.3.2	Town/ city	Graz
B.5.3.3	Post code	8036
B.5.3.4	Country	Austria
B.5.4	Telephone number	43316385 13911
B.5.5	Fax number	43316385 385 13491
B.5.6	E-mail	anaesthesie.neuro@medunigraz.at

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	DORMICUM "Roche" 5 mg/5 ml - Injektionslösung
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Austria GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Austria
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MIDAZOLAM HYDROCHLORIDE
D.3.9.1	CAS number	59467-96-8
D.3.9.4	EV Substance Code	SUB03289MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Vergleichende Untersuchung für hypnosedatives Management im Rahmen der Schlafvideoendoskopie (SVE) bei Patienten mit obstruktiven Schlafapnoesyndrom - Pilotstudie

E.1.1.1

Medical condition in easily understood language

partielle Verlegung der oberen Atemwege, dadurch Einschränkung Atmung

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	SOC
E.1.2	Classification code	10038738
E.1.2	Term	Respiratory, thoracic and mediastinal disorders
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Es soll bei dieser vergleichenden Studie herausgefunden werden, ob eine Prämedikation mit Dormicum in Kombination mit einem kurzwirksamen Hypnotikum zu einem schnelleren Eintreten eines dem natürlichen Schlafzustand mit sichtbaren oszillierenden Motilitätsmustern des Gewebes der oberen Atemwege ähnlichen Schlafäquivalentes führt.

E.2.2

Secondary objectives of the trial

Verringern der Gesamtdosis an Propofol als Hypnotikum Untersuchungsqualität für den Chirurgen

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patienten zwischen dem 18. – 70. Lebensjahr
ASA – Narkoserisiko – Klassifikation II – III
Patienten mit bevorstehender chirurgischer Intervention bei OSAS
Schriftliche Einwilligung der teilnehmenden Person nach erfolgter Aufklärung

E.4

Principal exclusion criteria

• Anamnetisch bekannte Überempfindlichkeit gegenüber einem der eingesetzten Medikamente oder deren Inhaltsstoffe oder gegenüber Medikamenten mit ähnlicher chemischer Struktur
Adipositas permagna BMI >40
allergisches Asthma bronchiale, COPD III (schwere chronisch obstruktive Lungenerkrankung, geringe respiratorische Belastungsreserve)
Keine chirurgische Intervention geplant
Nicht einwilligungsfähige Patienten

Bei zugelassenen Präparaten:
Midazolam:
Bekannte Überempfindlichkeit gegenüber Benzodiazepinen oder einem der sonstigen Bestandteile des Arzneimittels.
Propofol :
Überempfindlichkeit gegen Propofol, Soja, Erdnuss oder einen der sonstigen Bestandteile des Arzneimittels

E.5 End points

E.5.1

Primary end point(s)

Zeit bis zum erstmaligen Erreichen der am besten geeigneten Untersuchungsbedingungen für den HNO-Arzt gemessen in Minuten ab Schlafinduktion

E.5.1.1

Timepoint(s) of evaluation of this end point

Zeit bis zum erstmaligen Erreichen der am besten geeigneten Untersuchungsbedingungen für den HNO-Arzt gemessen in Minuten ab Schlafinduktion

E.5.2

Secondary end point(s)

VAS-Score für die Befunderhebungsqualität der Chirurgen (Zahlenwert 0 bis 10 : 0=keine Aussage möglich,10=bestmögliche Untersuchungsbedingungen)
Auftreten von obstruktiven / zentralen Apnoen
Auftreten von Abwehrbewegungen des Patienten
Schlafstadium (A bis F)
tiefste Entsättigung während Untersuchung
tiefste Entsättigung postoperativ
Gesamtdosis des verwendeten Hypnotikums während der ersten 10 Minuten der Untersuchung
Narkotrend Index bei Einsetzen des Schlafes und Auftreten der ersten sichtbaren oszillierenden Motilitätsmuster des Gewebes der oberen Atemwege

E.5.2.1

Timepoint(s) of evaluation of this end point

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

last patient last visit

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.2.1	Number of subjects for this age range:	12
F.1.3	Elderly (>=65 years)	Yes
F.1.3.1	Number of subjects for this age range:	12
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	12

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-11-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-12-16

P. End of Trial
P.	End of Trial Status	Ongoing

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