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The impact of controllable pressure oscillation Continuous positive airway pressure device in obstructive sleep apnea patients

The impact on the apnea/hypopnea index of controllable pressure oscillation Continuous positive airway pressure device in obstructive sleep apnea patients

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000165684
Enrollment
12
Registered
2014-02-11
Start date
2013-01-24
Completion date
2013-09-05
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

to compare the effects of a small superimposed pressure oscillation (PO) to a standard CPAP, in the treatment of sleep apnoeas

Interventions

Pressure oscillation (PO) superimposed to a standard continous positive airway pressure (CPAP) for the treatment of sleep apnoea. a) Continuous positive airway pressure (CPAP) is the standard treatment for obsructive sleep apnea. CPAP is a pressure applied through a mask by a constant flow that allows to open the upperairway during sleep. In this study we will test if small fluctuations in air pressure superimposed to a standard CPAP allows a better control of apneas during sleep. Thus, partici

Pressure oscillation (PO) superimposed to a standard continous positive airway pressure (CPAP) for the treatment of sleep apnoea. a) Continuous positive airway pressure (CPAP) is the standard treatment for obsructive sleep apnea. CPAP is a pressure applied through a mask by a constant flow that allows to open the upperairway during sleep. In this study we will test if small fluctuations in air pressure superimposed to a standard CPAP allows a better control of apneas during sleep. Thus, participants will undergo polysomnography for 2 consecutive nights. b) Patients will sleep one night in the sleep laboratory with their standard CPAP and one night with the new device, incorporating a superimposed pressure oscillation to the CPAP, in a random order. A polysomnography will be performed during the studied nights to monitor sleep and respiratory parameters. Participants will undergo polysomnography for 2 consecutive nights c) During the CPAP night patients will receve their habitual pressure. During the PO-CPAP night they will receive their habitual CPAP pressure +/- 1 cmH2O d) The duration of the study will be 2 nights: participants will be using standard CPAP for one night and PO-CPAP in one night. e) Patients will be monitored and assisted during the entire night by a specialized polysomnography technician

Sponsors

Lausanne University Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Patients with sleep apnoea syndrome currently treated with standard CPAP

Exclusion criteria

Unstable cardiovascular comorbidities (as unstable coronary heart disease, severe cardiac arrhythmias, congestive cardiac failure, non controlled hypertension)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026