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Therapy Adherence of APAP Therapy Initiation in Sleep-lab Versus at Home

NCT02339597 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2015-01-15

No results posted yet for this study

Summary

Primary hypothesis:

The objective compliance ( # of hours per night of APAP therapy) is higher in patients who get the APAP treatment initiation at home due to the fact that they get better support by telemetric control and the possibility of prompt interventions.

Secondary hypothesis:

Based on the higher support at the home APAP initiation the following parameters will be better in comparison to the standard supply in laboratory:

Objective measures:

* mask leakage
* pressure
* Apnea-Hypopnea-Index (AHI)

Subjective measures:

* quality of life
* sleepiness

Conditions

  • Patient Compliance

Interventions

PROCEDURE

Automatic Positive Airway Pressure (APAP) initiation

Sponsors & Collaborators

  • ResMed

    collaborator INDUSTRY

  • Prof. Dr. Ingo Fietze

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02339597 on ClinicalTrials.gov