CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Standard AutoSet algorithm +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01826513
NCT01826513N/ACompleted
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AutoSet for Her Clinical Trial Protocol

ResMed·interventional·Posted Apr 8, 2013·Updated Mar 27, 2017

In Brief

A clinical study evaluating Standard AutoSet algorithm and Modified AutoSet algorithm for Obstructive Sleep Apnea. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients. Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm. User preference will be evaluated by subjective feedback relating to comfort, ease of falling asleep, sleep disturbance and feeling of being refreshed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea
CountriesAustralia
CollaboratorsThe University of Western Australia

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 8, 2013
Enrollment StartMay 1, 2013
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.2 years ago

Interventions

Standard AutoSet algorithmdevice

An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.

Modified AutoSet algorithmdevice

An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.