CPAP In-home Assessment USA

Obstructive Sleep Apnea Clinical Trial

Official title:

CPAP In-home Assessment USA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809859
• Other study ID #: CIA176
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: April 2017

Study information

• Verified date: February 2019
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.

Description:

Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Aged 22 and over

• Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)

• For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.

Exclusion Criteria:

• Contraindicated for PAP (CPAP or AutoCPAP) therapy

• Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)

• Has obesity hypoventilation syndrome or congestive heart failure

• Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device

• Has implanted electronic medical devices (e.g cardiac pacemakers)

• Pregnant or think they may be pregnant

• Not fluent in spoken and written English.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Fisher & Paykel Healthcare CPAP Device
Fisher & Paykel Healthcare CPAP Device

Locations

Country	Name	City	State
United States	Ohio Sleep Medicine and Neurosciences Institute	Dublin	Ohio
United States	Alabama Sleep Clinic	Huntsville	Alabama
United States	Pulmonary Disease Specialists - Central Florida Sleep Centre	Kissimmee	Florida
United States	Clayton Sleep Institute	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.		6 months
Primary	Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults		6 months
Primary	Machine Reported Faults, Measured as Number of Patients With Machine Faults		6 months
Primary	Participant Reported Faults, Measured as Number of Participant Complaints		6 months
Secondary	How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device		6 months