FEM-PAP: AutoSet for Her Quality of Life Clinical Trial

• Sponsor: ResMed (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02400073
• Collaborator: (none)
• Enrollment: 122
• Locations: 3
• Arm: 1
• Actual Duration (Months): 52.6
• Patients Per Site: 40.7
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: N/A
• 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: Mar 19, 2015
• Actual Primary Completion Date: Jan 5, 2017
• Actual Study Completion Date: Aug 7, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ) [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sleep and Ventilation Center	Blaubeuren	Ulm	Germany
2	Advanced Sleep Research GmbH	Berlin		Germany	10117
3	Hospital Universitario de Valme.	Sevilla		Spain	41014

Sponsors and Collaborators

• ResMed

Investigators

• Principal Investigator: Francisco Campos-Rodríguez, Prof, Hospital Universitario de Valme

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ResMed
• ClinicalTrials.gov Identifier: NCT02400073
• Other Study ID Numbers: MA230315
• First Posted: Mar 26, 2015
• Last Update Posted: Oct 2, 2019
• Last Verified: Sep 1, 2019

• Additional relevant MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Study Results

Participant Flow

Recruitment Details	A total of 122 patients (25 from Spain and 97 from Germany) were enrolled in the study

Arm/Group Title	AutoSet for Her PAP Device
Arm/Group Description	Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA AutoSet for Her: 3 months nightly usage of the AutoSet for Her device
Period Title: Overall Study
STARTED	122
COMPLETED	111
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	AutoSet for Her PAP Device
Arm/Group Description	Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA AutoSet for Her: 3 months nightly usage of the AutoSet for Her device
Overall Participants	122
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.7 (9.5)
Sex: Female, Male (Count of Participants)
Female	122 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Germany	97 79.5%
Spain	25 20.5%

Outcome Measures

1. Primary Outcome

Title	Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ)
Description	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
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AutoSet for Her PAP Device
Arm/Group Description	Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA AutoSet for Her: 3 months nightly usage of the AutoSet for Her device
Measure Participants	111
Mean (Standard Deviation) [score on a scale]	1.9 (3.3)

2. Secondary Outcome

Title	Sleep Changes Assessed Through Polysomnography
Description	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
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AutoSet for Her PAP Device
Arm/Group Description	Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA AutoSet for Her: 3 months nightly usage of the AutoSet for Her device
Measure Participants	111
change in sleep efficacy	0.3 (2.1)
change in deep sleep	7 (3.1)
change in REM sleep	8.4 (0.5)

Adverse Events

Time Frame	3 months
Arm/Group Title	AutoSet for Her PAP Device
Arm/Group Description	Patients in this study will use the AutoSet for Her: A new AutoSetting Positive Airway Pressure (PAP) device designed specifically to treat female OSA AutoSet for Her: 3 months nightly usage of the AutoSet for Her device
All Cause Mortality
	AutoSet for Her PAP Device
	Affected / at Risk (%)	# Events
Total	0/122 (0%)
Serious Adverse Events
	AutoSet for Her PAP Device
	Affected / at Risk (%)	# Events
Total	0/122 (0%)
Other (Not Including Serious) Adverse Events
	AutoSet for Her PAP Device
	Affected / at Risk (%)	# Events
Total	0/122 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.