MedTrace Logo

AutoSet for Her Clinical Trial Protocol

NCT01826513 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-03-27

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients.

Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm.

User preference will be evaluated by subjective feedback relating to comfort, ease of falling asleep, sleep disturbance and feeling of being refreshed.

Conditions

Interventions

DEVICE

Standard AutoSet algorithm

An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.

DEVICE

Modified AutoSet algorithm

An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.

Sponsors & Collaborators

  • The University of Western Australia

    collaborator OTHER

  • ResMed

    lead INDUSTRY

Principal Investigators

  • Peter Eastwood, MBBS FRACP · Centre for Sleep Science, University of Western Australia

  • David Hillman, MBBS FRACP · West Australian Sleep Disorders Reserach Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT01826513 on ClinicalTrials.gov