Back to resultsAutoSet for Her Quality of Life Clinical Trial (FEM-PAP)
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AutoSet for Her
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- Sleep and Ventilation Center
- Advanced Sleep Research GmbH
- Hospital Universitario de Valme.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AutoSet for Her PAP device
Arm Description
Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02400073
Brief Title
AutoSet for Her Quality of Life Clinical Trial
Acronym
FEM-PAP
Official Title
Assessment of a New AutoSet Device Designed for Female Obstructive Sleep Apnea Patients on the Quality of Life of Users
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 19, 2015 (Actual)
Primary Completion Date
January 5, 2017 (Actual)
Study Completion Date
August 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AutoSet for Her PAP device
Arm Type
Experimental
Arm Description
Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA
Intervention Type
Device
Intervention Name(s)
AutoSet for Her
Intervention Description
3 months nightly usage of the AutoSet for Her device
Primary Outcome Measure Information:
Title
Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ)
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Sleep Changes Assessed Through Polysomnography
Description
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
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Campos-Rodríguez, Prof
Organizational Affiliation
Hospital Universitario de Valme
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep and Ventilation Center
City
Blaubeuren
State/Province
Ulm
Country
Germany
Facility Name
Advanced Sleep Research GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Hospital Universitario de Valme.
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
12. IPD Sharing Statement
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AutoSet for Her Quality of Life Clinical Trial
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