AutoSet for Her Quality of Life Clinical Trial

NCT ID: NCT02400073

Last Updated: 2019-10-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-19

Study Completion Date

2019-08-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

AutoSet for Her

Intervention Type DEVICE

3 months nightly usage of the AutoSet for Her device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AutoSet for Her

3 months nightly usage of the AutoSet for Her device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ResMed

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Francisco Campos-Rodríguez, Prof

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Valme

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sleep and Ventilation Center

Blaubeuren Abbey, Ulm, Germany

Site Status

Advanced Sleep Research GmbH

Berlin, , Germany

Site Status

Hospital Universitario de Valme.

Seville, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MA230315

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

SensAwake™ Sleep Quality Trial
NCT00811213 COMPLETED PHASE4