Evaluation of APAP With SensAwake in OSA and Insomnia Patients

Fisher & Paykel Healthcare

Status: Completed

Conditions: Insomnia; Obstructive Sleep Apnea

Treatments: Device: APAP with SensAwake; Device: APAP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02721329

2015-000407-57 (EudraCT Number)

CIA-151

Details and patient eligibility

About

The hypothesis is that APAP with SensAwake improves wake-after sleep onset compared to APAP without SensAwake in a patient population with Obstructive Sleep Apnea Syndrome (OSAS) and Insomnia.

Full description

Patients with OSA and Insomnia will be enrolled into this randomized study to receive treatment with APAP with and without SensAwake. Baseline data will be collected for one week prior to CPAP initiation, followed by two treatment periods on each study arm of four weeks each.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Older than 18 years of age.
• Diagnosed with OSA and eligible for CPAP treatment under local requirements (AHI>30 with no more than 20% of central respiratory events)
• Naïve to CPAP therapy, i.e. have not been prescribed, or used CPAP in the last 5 years.
• Fluent in spoken and written French

Exclusion criteria

• Significant uncontrolled cardiac disease, as per the principal investigator's discretion, and/or Left Ventricular Ejection Fraction (LVEF) < 45%
• Co-existing lung disease, as per the principal investigator's discretion
• Co-existing sleep disorder, such as predominant central sleep apnea
• Previous or current diagnosis of sleep phase delay
• Pregnancy
• Participants that are unable or unwilling to give informed consent
• Receiving cognitive behavioral therapy or other intervention to treat insomnia. Subjects may be using hypnotics, but there shall be no change in hypnotic use during the protocol or 4 weeks preceding enrolment into the study.
• Diagnosed with clinical depression and/or currently using anti-depressants and/or anti-anxiolytics within the last 6 months.
• Hospital Anxiety OR Depression score > 11
• Participating in another research study for the duration of participation in this study. Participation in an observational study or genetic study is permitted at the discretion of the investigator.
• Patient protected by the Law, under guardianship or curators, as defined in Public Health Code in articles from L1121-5 to L1121-8.
• Patient not covered by a health insurance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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19 participants in 2 patient groups

APAP without SensAwake

Active Comparator group

Description:

Auto CPAP delivered from the ICON+ CPAP device.

Treatment:

Device: APAP

APAP with SensAwake

Experimental group

Description:

Auto CPAP with SensAwake turned on and set at a pressure of 4cmH2O. SensAwake is a pressure relief function that reduces the CPAP pressure on the transition from sleep to wake.

Treatment:

Device: APAP with SensAwake