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AutoSet for Her Quality of Life Clinical Trial (FEM-PAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02400073
Recruitment Status : Completed
First Posted : March 26, 2015
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
ResMed

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: AutoSet for Her Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of a New AutoSet Device Designed for Female Obstructive Sleep Apnea Patients on the Quality of Life of Users
Actual Study Start Date : March 19, 2015
Actual Primary Completion Date : January 5, 2017
Actual Study Completion Date : August 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: 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
Device: AutoSet for Her
3 months nightly usage of the AutoSet for Her device




Primary Outcome Measures :
  1. Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: 3 months ]
    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


Secondary Outcome Measures :
  1. Sleep Changes Assessed Through Polysomnography [ Time Frame: 3 months ]
    assessment of sleep quality (sleep efficacy, amounts of deep sleep, amounts of REM sleep). The outcome measure is changes in sleep from baseline at 3 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400073


Locations
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Germany
Sleep and Ventilation Center
Blaubeuren, Ulm, Germany
Advanced Sleep Research GmbH
Berlin, Germany, 10117
Spain
Hospital Universitario de Valme.
Sevilla, Spain, 41014
Sponsors and Collaborators
ResMed
Investigators
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Principal Investigator: Francisco Campos-Rodríguez, Prof Hospital Universitario de Valme

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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT02400073    
Other Study ID Numbers: MA230315
First Posted: March 26, 2015    Key Record Dates
Results First Posted: October 2, 2019
Last Update Posted: October 2, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases