CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 122 enrolled
Drug / intervention
AutoSet for Herdevice
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/NCT02400073
NCT02400073N/ACompleted

Assessment of a New AutoSet Device Designed for Female Obstructive Sleep Apnea Patients on the Quality of Life of Users

ResMed·interventional·Posted Mar 26, 2015·Updated Oct 2, 2019

In Brief

A clinical study evaluating AutoSet for Her for Obstructive Sleep Apnea. Completed, enrolled 122 participants across 3 sites in 2 countries.

Detailed Summary

Obstructive sleep apnea (OSA) has detrimental effects on the health and quality of life of suffers. Recent literature has shown that females may be particularly susceptible to adverse the quality of life effects, and that female obstructive sleep apnea manifests differently than male obstructive sleep apnea. A new AutoSetting Positive Airway Pressure (PAP) device has been designed specifically to treat female OSA. In this Cohort study, female patients who are newly diagnosed with OSA will be asked to complete various questionnaires relating to their quality of life. Patients will then use the AutoSet for Her for three months. At the completion of the three months the questionnaires will be repeated. Before treatment and after treatment quality of life will be compared to determine if treating female specific OSA in these patients improves quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Spain
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 26, 2015
Enrollment StartMar 19, 2015
Primary CompletionJan 5, 2017
Study CompletionAug 7, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.3 years ago

Interventions

AutoSet for Herdevice

3 months nightly usage of the AutoSet for Her device