NCT02400073

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2017

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2019

Completed
2 months until next milestone

Results Posted

Study results publicly available

October 2, 2019

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

March 23, 2015

Results QC Date

August 7, 2019

Last Update Submit

September 12, 2019

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (1)

  • Sleep Changes Assessed Through Polysomnography

    3 months

Study Arms (1)

AutoSet for Her PAP device

EXPERIMENTAL

Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA

Device: AutoSet for Her

Interventions

AutoSet for HerDEVICE

3 months nightly usage of the AutoSet for Her device

AutoSet for Her PAP device

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sleep and Ventilation Center

Blaubeuren Abbey, Ulm, Germany

Location

Advanced Sleep Research GmbH

Berlin, 10117, Germany

Location

Hospital Universitario de Valme.

Seville, 41014, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Senior Manager, Medical Affairs
Organization
ResMed
alison.wimms@resmed.com
+61 8884 1123

Study Officials

  • Francisco Campos-Rodríguez, Prof

    Hospital Universitario de Valme

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

March 19, 2015

Primary Completion

January 5, 2017

Study Completion

August 7, 2019

Last Updated

October 2, 2019

Results First Posted

October 2, 2019

Record last verified: 2019-09

Locations

DE(2)ES(1)