Autoset T Versus CPAP Therapy, a Comparison of Titration... | NCT01303198

Studies
Autoset T Versus CPAP Therapy, a Comparison of Titration and Therapy

NCT01303198

Sponsor

Kaiserswerther Diakonie

Status

Unknown status

Last Update Posted

Feb 24, 2011Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Sleep Apnea Syndromes

Interventions

APAP - Therapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2001

Primary Completion Date

Apr 2011Estimated

Completion Date

Apr 2011Estimated

First Submitted Date

Feb 22, 2011

First Submission Date that Met QC Criteria

Feb 23, 2011

First Posted Date

Feb 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2011

Last Update Posted Date

Feb 24, 2011Estimated

Name	Class
ResMed Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Part 1.Comparison of manual pressure titration in laboratory of sleep disorders with Autoset T APAP device from Resmed. Hypothesis: There is no difference in efficiency between manual and automatical titration.

Part 2. Comparison of CPAP and APAP therapy in the home while 3 month by Questionaire and device data.

Hypothesis: There is a difference in compliance and efficiency between CPAP and APAP mode.

Detailed Description

A cross over, simple blind study design has been created for a controlled trial to compare pressure titration and therapy with the Autoset T device.

Part 1: After a baseline polysomnography (PSG) a selected group of patients with obstructive sleep apnea will be titrated in two more nights in a sleep lab under APAP mode and CPAP mode. We compare the sleep quality and the AHI, oxygen saturation, leakage.

Part 2: Over a time range of 12 weeks the patients got two kinds of therapy modes at home: CPAP and APAP (each six weeks. We compare the objective and subjective therapy by compliance, device data, Epworth sleepiness scale, Pittsburgh Sleep Quality Index (PSQI, german version).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CPAP	Active Comparator	Use of CPAP as treatment for sleep apnea	Device: APAP - Therapy
APAP	Active Comparator	Use of APAP as treatment for sleep apnea	Device: APAP - Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
APAP - Therapy	Device	automatic positive pressure therapy	APAP CPAP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AHI- score (apnea- hypopnea- index)	AHI (apnea- hypopnea- index): Number of Apneas and Hypopneas/hour as a function of the type of positive airway pressure supply used- automated (APAP) vs. the standard, manually titrated and fixes continuous (CPAP).	3 months

Secondary Outcomes

Measure	Description	Time Frame
Number of device-using hours	Number of device-using hours as a means to assess patient compliance with the treatment	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age from 18 to 80 years

Exclusion Criteria:

pregnancy
insomnia
consumption of soporifics
pulmonal or cardial diseases
operation advised by ear, nose and throat specialist
missing linguistic skills in german

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hartmut Grüger	Contact	0211 4093519		grueger@kaiserswerther-diakonie.de

Overall Officials

Name	Affiliation	Role
Hartmut Grueger, Arzt	Diakonie Kaiserswerth	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Florence-Nightingale-Krankenhaus	Recruiting	Düsseldorf	Nordrhein Westphalen	40489	Germany

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

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