Obstructive Sleep Apnea
Conditions
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.
Interventions
DEVICEAutoSet for Her
3 months nightly usage of the AutoSet for Her device
Sponsors
ResMed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany, Spain
Participant flow
Recruitment details
A total of 122 patients (25 from Spain and 97 from Germany) were enrolled in the study
Participants by arm
| Arm | Count |
|---|---|
| AutoSet for Her PAP Device Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA
AutoSet for Her: 3 months nightly usage of the AutoSet for Her device | 122 |
| Total | 122 |
Baseline characteristics
| Characteristic | AutoSet for Her PAP Device | — |
|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 9.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 97 participants | — |
| Region of Enrollment Spain | 25 participants | — |
| Sex: Female, Male Female | 122 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 122 |
| other Total, other adverse events | 0 / 122 |
| serious Total, serious adverse events | 0 / 122 |
Outcome results
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AutoSet for Her PAP Device | Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ) | 1.9 score on a scale | Standard Deviation 3.3 |
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
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AutoSet for Her PAP Device | Sleep Changes Assessed Through Polysomnography | change in sleep efficacy | 0.3 minutes | Standard Deviation 2.1 |
| AutoSet for Her PAP Device | Sleep Changes Assessed Through Polysomnography | change in deep sleep | 7 minutes | Standard Deviation 3.1 |
| AutoSet for Her PAP Device | Sleep Changes Assessed Through Polysomnography | change in REM sleep | 8.4 minutes | Standard Deviation 0.5 |