N/A
Completed N=122
AutoSet for Her Quality of Life Clinical Trial
Source: ClinicalTrials.gov NCT02400073 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ) — 1.9 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ) |
1.9 | — |
| SECONDARY Sleep Changes Assessed Through Polysomnography |
0.3; 7; 8.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT02400073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.