Klinische Studien

READ ASV Registry

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
NCT03032029

Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation / READ-ASV Registry A non-interventional, observational, prospective study

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

Changes in Functional Outcomes of Sleep Questionnaire (FOSQ) score comparing baseline with data at 12 ± 3 months of follow-up.

Secondary Outcomes

Changes in:

Daytime sleepiness, measured by Epworth Sleepiness Scale (ESS), comparing baseline with 12 ± 3 months of follow-up;

EuroQol five dimensions questionnaire (EQ-5D) score, comparing baseline with data at 12 ± 3 months of follow-up.

Relation of usage patterns of ASV therapy as measured by:

changes in ESS and EQ-5D scores and daytime symptoms between following usage patterns groups: usage per night ≥ 4 hours/< 4 hours and usage ≥ 70% of days; residual AHI of < 5/h, 5-15/h and > 15/h,

Diagnosis

Target population

Age

18-

Inclusion criteria

≥ 18 years old

Indication for treatment with ASV according to applicable medical guidelines

Use of eligible ResMed devices for treatment with ASV according to the Instructions For Use of the corresponding device.

Naive to ASV treatment (max. 7 days between start of ASV therapy and enrolment).

Able to fully understand information on data protection and provide written informed consent for use of their medical data

Exclusion criteria

Chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.

 

It is recommended in routine clinical care that subsequent clinical visits should be performed 1–2 times a year. Within this observational study at least one follow-up (FU) should be reported for each patient at 12 months (with a time frame of +/- 3 months in clinical routine) following enrolment.

Study design

  • Multicenter

Documents (password protected)

Responsibilities in overall study

Study Sites

Med. Klinik 3 Pneumologie - Klinikum Nürnberg

Postal Address
Med. Klinik 3 Pneumologie - Klinikum Nürnberg
Medizinische Klinik III Pneumologie
Klinikum Nürnberg Nord
Prof.-Ernst-Nathan-Str. 1
Nürnberg
Visitor Address
Med. Klinik 3 Pneumologie - Klinikum Nürnberg
Klinikum Nürnberg Nord
Prof.-Ernst-Nathan-Str. 1
90419 Nürnberg
Haus: Haus 14, Sockelgeschoß

Study office

Status

Active (Recruitment Closed)

Principal Investigator

Prof. Dr. Joachim H. Ficker

Deputy of Principal Investigator

  • Dr. med. D. Triché

Contact at Site

 
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