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

January 12, 2015 updated by: Prof. Dr. Ingo Fietze

Therapy Adherence in Different Settings of Automatic Positive Airway Pressure (APAP) Therapy Initiation in Patients With Obstructive Sleep Apnea (OSA): Comparison Between in Sleep-lab vs. at Home Environment.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charite-Universitaetsmedizin Berlin, Center for Sleep Medicine
        • Contact:
        • Principal Investigator:
          • Ingo Fietze, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written informed consent from patients after verbally and written informing
  • Age between 18 and 80 Years
  • obstructive sleep apnea syndrome (OSAS) with an AHI > 15/h and without previous therapy

Exclusion Criteria:

  • Intolerance to wear the PAP therapy mask
  • sleep breathing disorders (SBD) with central apneas > 20% and other sleep disorders
  • disabilities who prevents the wear of a therapy mask
  • initiated PAP therapy
  • pre-treatment of OSAS incl. UPPP (uvulo palato pharyngo plasty)
  • modified Mallampati Score T3 and T4
  • participation on clinical studies 4 weeks before start of the study
  • known or acute psychiatric/neurological or psychological disorders, who impairs the compliance to take part of the study.
  • chronical or new clinically significant pneumological or cardiovascular disease (exception: effectively therapies of hypertension, cardiac arrhythmia and coronal cardiac disease)
  • acute internistic disease
  • neuromuscular disease
  • condition after Apoplexy
  • oncological disease in recent 5 years
  • drug/alcohol consumption
  • consumption of von psychotropic drugs, hypnotics and other drugs who are able to influence the sleep/wake cycle

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APAP Lab
standard Initiation of APAP therapy in sleep laboratory.
Procedure: Automatic Positive Airway Pressure (APAP) initiation
Experimental: APAP Home
initiation of APAP therapy in homely environment with additional continuous telemetric support.
Procedure: Automatic Positive Airway Pressure (APAP) initiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of usage hours of of positive airway pressure therapy per night
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Apnea Hypopnea Index [1 / hour of sleep)
Time Frame: 6 month
6 month

Other Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Ingo Fietze

Collaborators

ResMed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 15, 2015

Study Record Updates

Last Update Posted (Estimate)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • EA1/306/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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