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

Patient Compliance Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02339597
• Other study ID #: EA1/306/13
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2014
• Last updated: January 12, 2015
• Start date: January 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2015
• Source: Charite University, Berlin, Germany
• Contact: Ingo Fietze, MD, PhD
• Phone: +4930450513160
• Email: ingo.fietze[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Patient Compliance

Intervention

Procedure:
• Automatic Positive Airway Pressure (APAP) initiation

Locations

Country	Name	City	State
Germany	Charite-Universitaetsmedizin Berlin, Center for Sleep Medicine	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dr. Ingo Fietze	ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life		6 month	No
Primary	Number of usage hours of of positive airway pressure therapy per night		6 month	No
Secondary	Apnea Hypopnea Index [1 / hour of sleep)		6 month	No