AutoSet for Her Quality of Life Clinical Trial

NCT02400073 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2019-10-02

Study results available
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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.

Conditions

Interventions

DEVICE

AutoSet for Her

3 months nightly usage of the AutoSet for Her device

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Principal Investigators

  • Francisco Campos-Rodríguez, Prof · Hospital Universitario de Valme

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-19
Primary Completion
2017-01-05
Completion
2019-08-07

Countries

  • Germany
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02400073 on ClinicalTrials.gov