AutoSet for Her Quality of Life Clinical Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: AutoSet for Her


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AutoSet for Her PAP device<br>Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA | Device: AutoSet for Her<br>* 3 months nightly usage of the AutoSet for Her device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |