AutoSet for Her Quality of Life Clinical Trial

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: AutoSet for Her

• Registration Number: NCT02400073
• Lead Sponsor: ResMed

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-19
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Primary Completion: 2017-01-05
• Study Completion: 2019-08-07
• Results First Submitted: 2019-08-07
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-12
• Last Update Submitted: 2019-09-12
• Results First Posted: 2019-10-02
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 122

Inclusion Criteria

• Females aged ≥ 18 years
• Diagnostic PG/ PSG showing at least moderate OSA (AHI ≥ 15)
• Indication for PAP
• Participants willing and able to give written informed consent
• Ability to tolerate PAP therapy

Exclusion Criteria

• Participants currently using CPAP or who have previous experience with CPAP
• Participants currently using supplemental oxygen
• Participants who are pregnant or planning to become pregnant in the next 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AutoSet for Her PAP device	AutoSet for Her	Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA

Primary Outcome Measures

Name	Time	Method
Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ)	3 months	The Functional Outcomes of Sleep Questionnaire (FOSQ) assesses quality of life based on self reported physical and mental health. The outcome measure is Change from Baseline FOSQ score at 3 months. The minimum score is 5 and the maximum score is 20. Higher scores represent a better outcome

Secondary Outcome Measures

Name	Time	Method
Sleep Changes Assessed Through Polysomnography	3 months	assessment of sleep quality (sleep efficacy, amounts of deep sleep, amounts of REM sleep). The outcome measure is changes in sleep from baseline at 3 months

Trial Locations

Locations (3)

Sleep and Ventilation Center; 🇩🇪 Blaubeuren, Ulm, Germany

Advanced Sleep Research GmbH; 🇩🇪 Berlin, Germany

Hospital Universitario de Valme.; 🇪🇸 Sevilla, Spain