NCT02400073

AutoSet for Her Quality of Life Clinical Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: ResMed · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	AutoSet for Her	3 months nightly usage of the AutoSet for Her device

Timeline

• Start date: 2015-03-19
• Primary completion: 2017-01-05
• Completion: 2019-08-07
• First posted: 2015-03-26
• Last updated: 2019-10-02
• Results posted: 2019-10-02

Locations

3 sites across 2 countries: Germany, Spain