NCT01303198

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

9.8 years

First QC Date

February 22, 2011

Last Update Submit

February 23, 2011

Conditions

Sleep Apnea Syndromes

Keywords

CPAPAPAPsleep apnea

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Number of device-using hours

    3 months

Study Arms (2)

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

APAP - TherapyDEVICE

automatic positive pressure therapy

APAPCPAP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age from 18 to 80 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florence-Nightingale-Krankenhaus

Düsseldorf, Nordrhein Westphalen, 40489, Germany

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Hartmut Grueger, Arzt

    Diakonie Kaiserswerth

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hartmut Grüger

CONTACT

0211 4093519grueger@kaiserswerther-diakonie.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 24, 2011

Study Start

June 1, 2001

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

DE(1)