N/A Completed N=20 Randomized Single-blind Treatment

Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.

sleep apnea

Source: ClinicalTrials.gov NCT00906958 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcomePrimary: Apnoea-Hypopnoea Index (AHI) — 1.69; 1.73 Events/Hour

Summary

The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.

Outcome Measures

Outcome	Result	p-value
PRIMARY Apnoea-Hypopnoea Index (AHI)	1.69; 1.73	—
PRIMARY Oxygen Desaturation Index	1.95; 1.68	—
SECONDARY Comfort of Breathing	8.0; 7.0	—
SECONDARY Satisfaction of Treatment	9.5; 8.0	—
SECONDARY Refreshed Feel	9.0; 8.0	—

Eligibility Criteria

Inclusion Criteria

Patients aged 18-80 years
Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months
Patients who are using ResMed masks

Exclusion Criteria

Patients who are unable to provide written informed consent
Patients who are unable to comprehend written and spoken English
Patients who are using Bilevel PAP
Patients who are pregnant
Patients who are suffering any of the following:
Acute respiratory infection
Acute sinusitis, otitis media or perforated eardrum
Pneumothorax or pneumomediastinum
Recent history of severe epistaxis requiring medical attention

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00906958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.