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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00733343




Registration number
NCT00733343
Ethics application status
Date submitted
14/02/2008
Date registered
13/08/2008
Date last updated
12/05/2020

Titles & IDs
Public title
Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure
Scientific title
Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure
Secondary ID [1] 0 0
ISRCTN19572887
Secondary ID [2] 0 0
01
Universal Trial Number (UTN)
Trial acronym
Serve-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Sleep Disordered Breathing 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Europe: AutoSet CS (USA: VPAP Adapt SV)

Active comparator: Treatment Group - treatment with Adaptive Servoventilation (Europe: AutoSet CS (USA: VPAP (Variable Positive Airway Pressure) Adapt SV)) + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)

No intervention: Control Group - standard medical therapy according to applicable guidelines (ESC, ACC/AHA)


Treatment: Devices: Europe: AutoSet CS (USA: VPAP Adapt SV)
At least 3 hours average daily usage time
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure
Timepoint [1] 0 0
time to first event, assessed for up to 70 weeks
Primary outcome [2] 0 0
Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure
Timepoint [2] 0 0
time to first event, assessed for up to 70 weeks
Primary outcome [3] 0 0
All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation
Timepoint [3] 0 0
time to first event, assessed for up to 70 weeks
Secondary outcome [1] 0 0
Death From Any Cause
Timepoint [1] 0 0
the last follow up or at the last available observation within Follow Up (FU), assessed for up to 70 weeks
Secondary outcome [2] 0 0
Non-cardiovascular Death
Timepoint [2] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [3] 0 0
Cardiovascular Death
Timepoint [3] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [4] 0 0
Unplanned Hospitalisation/Prolongation of Hospitalisation Due to Worsening of Heart Failure
Timepoint [4] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [5] 0 0
Unplanned Hospitalisation/Prolongation of Hospitalisation for Other Reasons or Death
Timepoint [5] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [6] 0 0
Adequate Shock in Patients With ICD (Evaluation of Appropriateness Will Also be Made by the Endpoint Review Committee, ERC), Long-Term Atrial Defibrillator Insertion or Cardiovascular Death
Timepoint [6] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [7] 0 0
First Survived Resuscitation for Any Reason (Evaluation Will Also be Made by the ERC)
Timepoint [7] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [8] 0 0
First Survived Resuscitation of Sudden Cardiac Arrest (Evaluation Will Also be Made by the ERC)
Timepoint [8] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [9] 0 0
Age Baseline
Timepoint [9] 0 0
1 x at Baseline
Secondary outcome [10] 0 0
Body Weight Baseline
Timepoint [10] 0 0
1 x at baseline
Secondary outcome [11] 0 0
Body Mass Index (BMI) Baseline
Timepoint [11] 0 0
1 x baseline
Secondary outcome [12] 0 0
Left Ventricular Ejection Fraction at Baseline
Timepoint [12] 0 0
1x at baseline
Secondary outcome [13] 0 0
Blood Pressure Systolic Baseline
Timepoint [13] 0 0
1 x at baseline
Secondary outcome [14] 0 0
Blood Pressure Diastolic Baseline
Timepoint [14] 0 0
1 x at baseline
Secondary outcome [15] 0 0
Hemoglobine Baseline
Timepoint [15] 0 0
1 x at baseline
Secondary outcome [16] 0 0
Creatinine Baseline
Timepoint [16] 0 0
1 x at baseline
Secondary outcome [17] 0 0
Glomerular Filtration Rate Baseline
Timepoint [17] 0 0
1 x at baseline
Secondary outcome [18] 0 0
6-Min Walk Distance
Timepoint [18] 0 0
1 x at baseline
Secondary outcome [19] 0 0
Epworth Sleepiness Scale (ESS)
Timepoint [19] 0 0
1 x at baseline
Secondary outcome [20] 0 0
Apnoea-Hypopnea-Index (AHI) at Baseline
Timepoint [20] 0 0
1 x at baseline
Secondary outcome [21] 0 0
Central Apnoea Index/Total AHI
Timepoint [21] 0 0
1 x at baseline
Secondary outcome [22] 0 0
Central AHI/Total AHI at Baseline
Timepoint [22] 0 0
1 x at baseline
Secondary outcome [23] 0 0
Oxygen Desaturation Index (ODI) at Baseline
Timepoint [23] 0 0
1 x at baseline
Secondary outcome [24] 0 0
Oxygen Saturation Baseline
Timepoint [24] 0 0
1 x at baseline
Secondary outcome [25] 0 0
Time With Oxygen Saturation Below 90%
Timepoint [25] 0 0
1 x at baseline
Secondary outcome [26] 0 0
Time Until Unplanned Hospitalisation/Prolongation of Hospitalisation for Cardiovascular Cause or Cardiovascular Death/ Time Frame
Timepoint [26] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [27] 0 0
Percent of Follow up Days Which Patient Survives and is Not Hospitalized/Hospital Stay is Not Prolonged for Cardiovascular Cause
Timepoint [27] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [28] 0 0
Changes in NYHA Classification as Compared to Baseline
Timepoint [28] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [29] 0 0
Changes in QoL (Minnesota) as Compared to Baseline
Timepoint [29] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [30] 0 0
Changes in Renal Function (Based on Serum Creatinine) as Compared to Baseline
Timepoint [30] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [31] 0 0
Changes in Six Minute Walking Distance (6MWD) as Compared to Baseline
Timepoint [31] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [32] 0 0
Changes of AHI and Oxygen Desaturation Index Compared to Baseline
Timepoint [32] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [33] 0 0
AHI Below 10 Per Hour at Twelve Months and ODI Below 5 Per Hour at Twelve Months
Timepoint [33] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [34] 0 0
Atrial Fibrillation at Follow-up Visits
Timepoint [34] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [35] 0 0
Number and Cost of Hospitalisations (With Tariff/DRG, Diagnoses and Procedures for Calculating DRG or Length of Stay and Level of Care Provided)
Timepoint [35] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [36] 0 0
Difference in Utilities / QoL (Minnesota and EQ5D) Compared to Control Arm
Timepoint [36] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [37] 0 0
Difference in Cost of Resources Consumed
Timepoint [37] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [38] 0 0
Incremental Cost-efficacy Ratio
Timepoint [38] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks
Secondary outcome [39] 0 0
Incremental Cost-utility Ratio
Timepoint [39] 0 0
the last follow up or at the last available observation within FU, assessed for up to 70 weeks

Eligibility
Key inclusion criteria
* Patients must be at least 22 years old
* Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (ESC, ACC/AHA)
* Left ventricular systolic dysfunction (LVEF =45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks before randomisation
* NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months
* No hospitalisation for heart failure for at least 4 weeks prior to inclusion
* Optimised medical treatment according to applicable guidelines with no new class of disease modifying drug for more than 4 weeks prior to randomisation. In case of no beta blockers or ACE (angiotensin converting Enzyme) inhibitors/ ARB (angiotensin receptor blocker) antagonists the reasons must be documented
* SDB (AHI > 15/h with = 50% central events and a central AHI = 10/h, derived from polygraphy or polysomnography (based on total recording time (TRT)), documented less than 4 weeks before randomisation. Flow measurement has to be performed with nasal cannula
* Patients for whom the use of AutoSet CS2 (TM)/VPAP Adapt may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum
* Patient is able to fully understand study information and signed informed consent
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Significant COPD (chronic obstructive pulmonary disease) with Forced Expiratory Volume within one second (FEV1) <50% (European Respiratory Society criteria) in the last four weeks before randomisation
* Oxygen saturation at rest during the day = 90% at inclusion
* Current use of Positive Airway Pressure (PAP) - therapy
* Life expectancy < 1 year for diseases unrelated to chronic HF
* Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
* CRT (cardiac resynchronisation therapy)-implantation or ICD-implantation scheduled or within 6 months prior to randomisation
* Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
* Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
* Acute myocarditis/pericarditis within 6 months prior to randomisation
* Untreated or therapy refractory Restless legs-Syndrome (RLS) according to criteria listed in Appendix IX at the time of study entry
* Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
1325
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Rivercity Private Hospital - Auchenflower
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Melbourne Sleep Disorders Centre - East Melbourne
Recruitment hospital [5] 0 0
St Vincents and Mercy Private Hospital - Melbourne
Recruitment hospital [6] 0 0
Hollywood Private Hospital (CVS) - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3065 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Brno
Country [2] 0 0
Denmark
State/province [2] 0 0
Copenhagen
Country [3] 0 0
Denmark
State/province [3] 0 0
Glostrup
Country [4] 0 0
Denmark
State/province [4] 0 0
Århus C
Country [5] 0 0
Denmark
State/province [5] 0 0
Århus N
Country [6] 0 0
Finland
State/province [6] 0 0
Helsinki
Country [7] 0 0
Finland
State/province [7] 0 0
Tampere
Country [8] 0 0
France
State/province [8] 0 0
Amneville
Country [9] 0 0
France
State/province [9] 0 0
Angers
Country [10] 0 0
France
State/province [10] 0 0
Antibes
Country [11] 0 0
France
State/province [11] 0 0
Antony
Country [12] 0 0
France
State/province [12] 0 0
Belfort
Country [13] 0 0
France
State/province [13] 0 0
Besancon
Country [14] 0 0
France
State/province [14] 0 0
Beziers
Country [15] 0 0
France
State/province [15] 0 0
Bordeaux
Country [16] 0 0
France
State/province [16] 0 0
Caen Cedex
Country [17] 0 0
France
State/province [17] 0 0
Cannes
Country [18] 0 0
France
State/province [18] 0 0
Creteil
Country [19] 0 0
France
State/province [19] 0 0
Echirolles
Country [20] 0 0
France
State/province [20] 0 0
Forbach
Country [21] 0 0
France
State/province [21] 0 0
Grenoble
Country [22] 0 0
France
State/province [22] 0 0
Haguenau
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France
State/province [23] 0 0
L'Union
Country [24] 0 0
France
State/province [24] 0 0
Lille
Country [25] 0 0
France
State/province [25] 0 0
Lyon
Country [26] 0 0
France
State/province [26] 0 0
Metz
Country [27] 0 0
France
State/province [27] 0 0
Montbeliard
Country [28] 0 0
France
State/province [28] 0 0
Montpellier
Country [29] 0 0
France
State/province [29] 0 0
Montreuil
Country [30] 0 0
France
State/province [30] 0 0
Mulhouse
Country [31] 0 0
France
State/province [31] 0 0
Ollioules
Country [32] 0 0
France
State/province [32] 0 0
Paris
Country [33] 0 0
France
State/province [33] 0 0
Pessac
Country [34] 0 0
France
State/province [34] 0 0
Poitiers
Country [35] 0 0
France
State/province [35] 0 0
Pont-à-mousson
Country [36] 0 0
France
State/province [36] 0 0
Pontoise
Country [37] 0 0
France
State/province [37] 0 0
Rennes
Country [38] 0 0
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State/province [38] 0 0
Rouen
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State/province [39] 0 0
Saint Avold
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France
State/province [40] 0 0
Saint Louis
Country [41] 0 0
France
State/province [41] 0 0
Saint- Etienne
Country [42] 0 0
France
State/province [42] 0 0
St Dié des Vosges
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France
State/province [43] 0 0
Toulouse
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France
State/province [44] 0 0
Trouville
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France
State/province [45] 0 0
Vandoeuvre les Nancy
Country [46] 0 0
France
State/province [46] 0 0
Verdun
Country [47] 0 0
Germany
State/province [47] 0 0
Rheinland-Pfalz
Country [48] 0 0
Germany
State/province [48] 0 0
Aachen
Country [49] 0 0
Germany
State/province [49] 0 0
Alzey
Country [50] 0 0
Germany
State/province [50] 0 0
Arnsberg
Country [51] 0 0
Germany
State/province [51] 0 0
Bad Berka
Country [52] 0 0
Germany
State/province [52] 0 0
Bad Krozingen
Country [53] 0 0
Germany
State/province [53] 0 0
Bad Mergentheim
Country [54] 0 0
Germany
State/province [54] 0 0
Bad Oeynhausen
Country [55] 0 0
Germany
State/province [55] 0 0
Bautzen
Country [56] 0 0
Germany
State/province [56] 0 0
Bergheim
Country [57] 0 0
Germany
State/province [57] 0 0
Bergisch Gladbach
Country [58] 0 0
Germany
State/province [58] 0 0
Berlin
Country [59] 0 0
Germany
State/province [59] 0 0
Bernau
Country [60] 0 0
Germany
State/province [60] 0 0
Bielefeld
Country [61] 0 0
Germany
State/province [61] 0 0
Bochum
Country [62] 0 0
Germany
State/province [62] 0 0
Bonn
Country [63] 0 0
Germany
State/province [63] 0 0
Borna
Country [64] 0 0
Germany
State/province [64] 0 0
Bottrop
Country [65] 0 0
Germany
State/province [65] 0 0
Bremen
Country [66] 0 0
Germany
State/province [66] 0 0
Brühl
Country [67] 0 0
Germany
State/province [67] 0 0
Burg
Country [68] 0 0
Germany
State/province [68] 0 0
Castrop-Rauxel
Country [69] 0 0
Germany
State/province [69] 0 0
Chemnitz
Country [70] 0 0
Germany
State/province [70] 0 0
Coburg
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Germany
State/province [71] 0 0
Coswig
Country [72] 0 0
Germany
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Cottbus
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Germany
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Dortmund
Country [74] 0 0
Germany
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Dresden
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Germany
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Düsseldorf
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Germany
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Emmendingen
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Germany
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Erfurt
Country [78] 0 0
Germany
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Erlangen
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Germany
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Essen
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Germany
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Flonheim
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Germany
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Forst
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Germany
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Frankfurt
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Germany
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Frechen
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Germany
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Freiburg im Breisgau
Country [85] 0 0
Germany
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Gladbeck
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Germany
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Günzburg
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Germany
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Gütersloh
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Germany
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Hagen
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Hemer
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Germany
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Herne
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Germany
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Herten
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Germany
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Immenhausen
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Germany
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Karlstadt
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Germany
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Kassel
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Germany
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Kempen
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Germany
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Krefeld
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Germany
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Köln
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Germany
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Königs Wusterhausen
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Germany
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Leipzig
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Germany
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Leisnig
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Germany
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Lengerich
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Germany
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Lindlar
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Germany
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Lingen
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Germany
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Lübeck
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Marburg
Country [111] 0 0
Germany
State/province [111] 0 0
Meissen
Country [112] 0 0
Germany
State/province [112] 0 0
Memmingen
Country [113] 0 0
Germany
State/province [113] 0 0
Menden
Country [114] 0 0
Germany
State/province [114] 0 0
Moers
Country [115] 0 0
Germany
State/province [115] 0 0
Mühldorf
Country [116] 0 0
Germany
State/province [116] 0 0
Mülheim an der Ruhr
Country [117] 0 0
Germany
State/province [117] 0 0
München
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Germany
State/province [118] 0 0
Münster
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Germany
State/province [119] 0 0
Neuss
Country [120] 0 0
Germany
State/province [120] 0 0
Nienburg
Country [121] 0 0
Germany
State/province [121] 0 0
Nürnberg
Country [122] 0 0
Germany
State/province [122] 0 0
Ochtrup
Country [123] 0 0
Germany
State/province [123] 0 0
Radebeul
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Germany
State/province [124] 0 0
Ratingen
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Germany
State/province [125] 0 0
Ratzeburg
Country [126] 0 0
Germany
State/province [126] 0 0
Ravensburg
Country [127] 0 0
Germany
State/province [127] 0 0
Recklinghausen
Country [128] 0 0
Germany
State/province [128] 0 0
Regensburg
Country [129] 0 0
Germany
State/province [129] 0 0
Reinbek
Country [130] 0 0
Germany
State/province [130] 0 0
Rheine
Country [131] 0 0
Germany
State/province [131] 0 0
Schwerte
Country [132] 0 0
Germany
State/province [132] 0 0
Schönefeld
Country [133] 0 0
Germany
State/province [133] 0 0
Soest
Country [134] 0 0
Germany
State/province [134] 0 0
Sonneberg
Country [135] 0 0
Germany
State/province [135] 0 0
Stollberg
Country [136] 0 0
Germany
State/province [136] 0 0
Uelzen
Country [137] 0 0
Germany
State/province [137] 0 0
Ulm
Country [138] 0 0
Germany
State/province [138] 0 0
Unna
Country [139] 0 0
Germany
State/province [139] 0 0
Viersen
Country [140] 0 0
Germany
State/province [140] 0 0
Waldkraiburg
Country [141] 0 0
Germany
State/province [141] 0 0
Wangen
Country [142] 0 0
Germany
State/province [142] 0 0
Weißenhorn
Country [143] 0 0
Germany
State/province [143] 0 0
Witten
Country [144] 0 0
Germany
State/province [144] 0 0
Worms
Country [145] 0 0
Germany
State/province [145] 0 0
Würzburg
Country [146] 0 0
Germany
State/province [146] 0 0
Zweibrücken
Country [147] 0 0
Netherlands
State/province [147] 0 0
Groningen
Country [148] 0 0
Norway
State/province [148] 0 0
Oslo
Country [149] 0 0
Norway
State/province [149] 0 0
Stavanger
Country [150] 0 0
Sweden
State/province [150] 0 0
Göteborg
Country [151] 0 0
Sweden
State/province [151] 0 0
Jönköping
Country [152] 0 0
Sweden
State/province [152] 0 0
Lidköping
Country [153] 0 0
Sweden
State/province [153] 0 0
Linköping
Country [154] 0 0
Switzerland
State/province [154] 0 0
Lugano
Country [155] 0 0
United Kingdom
State/province [155] 0 0
East Yorkshire
Country [156] 0 0
United Kingdom
State/province [156] 0 0
Chesterfield
Country [157] 0 0
United Kingdom
State/province [157] 0 0
London
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Newcastle
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Taunton
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ResMed
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
CRI-The Clinical Research Institute GmbH
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Helmut Teschler, Prof.
Address 0 0
Universitätsklinikum Essen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT00733343