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OpenTrials
Completed

NCT Number: NCT02400073

AutoSet for Her Quality of Life Clinical Trial

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sleep and Ventilation Center, Blaubeuren Abbey, Ulm, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AutoSet for Her

Device

3 months nightly usage of the AutoSet for Her device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Assessment of a New AutoSet Device Designed for Female Obstructive Sleep Apnea Patients on the Quality of Life of Users

Acronym: FEM-PAP

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Mar 26, 2015
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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