AutoSet for Her Quality of Life Clinical Trial

Obstructive Sleep Apnea Clinical Trial

— FEM-PAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400073
• Other study ID #: MA230315
• Status: Completed
• Phase: N/A
• Start date: March 19, 2015
• Est. completion date: August 7, 2019

Study information

• Verified date: September 2019
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 7, 2019
• Est. primary completion date: January 5, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• AutoSet for Her
3 months nightly usage of the AutoSet for Her device

Locations

Country	Name	City	State
Germany	Advanced Sleep Research GmbH	Berlin
Germany	Sleep and Ventilation Center	Blaubeuren	Ulm
Spain	Hospital Universitario de Valme.	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ)	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	3 months
Secondary	Sleep Changes Assessed Through Polysomnography	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	3 months