Effectiveness of Auto-adjusted Continuous Positive Airway Pressure for Long-term Treatment of Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

Official title:

Effectiveness of Auto-adjusted Continuous Positive Airway Pressure for Long-term Treatment of Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280800
• Other study ID #: EK 1187
• Status: Completed
• Phase: N/A
• First received: January 20, 2006
• Last updated: October 26, 2017
• Start date: January 2006
• Est. completion date: March 2014

Study information

• Verified date: October 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypothesis: Computer controlled continuous positive airway pressure (autoCPAP) is equally effective in improving obstructive sleep apnea syndrome symptoms, breathing disturbances, objective vigilance, and it is cost-effective compared to conventional fixed continuous positive airway pressure.

Description:

1. To investigate whether computer controlled continuous positive airway pressure (autoCPAP) improves subjective sleepiness, quality of life, objective vigilance, and nocturnal respiration to a similar degree as conventional fixed continuous positive airway pressure in the initial phase of treatment and over the subsequent 2 years during home therapy

2. To investigate the cost of autoCPAP compared to fixed CPAP therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Excessive sleepiness, and Epworth Sleepiness Score > or = 8

• Apnea- Hypopnea-Index (AHI) > or = 10/hour

• Age 18-75

Exclusion Criteria:

• Psychophysiological incapacity to perform questionnaires

• Other sleep disorders

• Psychiatric disease requiring treatment

• Previous CPAP therapy

• Previous uvulopalatopharyngoplasty

• Chronic nasal obstruction that required treatment for more than 1 month

• Cancer

• COPD, with FEV1 < 50% predicted

• Symptomatic cardiovascular disease requiring treatment defined as congestive heart failure > NYHA II

• Previous stroke with neurological residuum

• Cheyne-Stokes respiration

• Chronic pain syndromes, fibromyalgia

• Drug or alcohol addiction

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• constant CPAP devices
different CPAP mode
• automatic CPAP devices
different CPAP mode

Locations

Country	Name	City	State
Switzerland	Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich	Zürich

Sponsors (5)

Lead Sponsor	Collaborator
Konrad E. Bloch	Cantonal Hospital of St. Gallen, Kantonsspital Münsterlingen, University of Zurich, Zuercher Hoehenklinik Wald

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective sleepiness and other OSAS symptoms		3 months, 1 year, 2 years
Primary	quality of life		3 months, 1 year, 2 years
Primary	percentage of withdrawal and cross-over to other CPAP mode		3 months, 1 year, 2 years
Primary	objective vigilance		3 months, 1 year, 2 years
Primary	blood pressure		3 months, 1 year, 2 years
Primary	cost/utility ratios		3 months, 1 year, 2 years
Secondary	major outcomes in subgroups of patients with severe and mild OSAS		3 months, 1 year, 2 years
Secondary	circulating markers of inflammation and cardiovascular risk		3 months, 1 year, 2 years
Secondary	side effects		3 months, 1 year, 2 years
Secondary	nocturnal respiratory disturbances		3 months, 1 year, 2 years
Secondary	treatment adherence		3 months, 1 year, 2 years

External Links

•   Bloch KE et al. Thorax 2017;0:1-11
•   Link to publication