Evaluation of APAP With SensAwake in OSA and Insomnia Patients

NCT ID: NCT02721329

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-03-31

Brief Summary

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.

Detailed 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.

Conditions

Obstructive Sleep Apnea; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

APAP without SensAwake

Auto CPAP delivered from the ICON+ CPAP device.

Group Type: ACTIVE_COMPARATOR

APAP

Intervention Type: DEVICE

Automatic Continuous Positive Airway Pressure

APAP with SensAwake

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.

Group Type: EXPERIMENTAL

APAP with SensAwake

Intervention Type: DEVICE

Automatic Continuous Positive Airway Pressure with SensAwake enabled. SensAwake is a pressure relief technology that detects the transition from sleep to wake, and promptly reduces the pressure during wakeful periods.

Interventions

APAP

Automatic Continuous Positive Airway Pressure

Intervention Type: DEVICE

APAP with SensAwake

Automatic Continuous Positive Airway Pressure with SensAwake enabled. SensAwake is a pressure relief technology that detects the transition from sleep to wake, and promptly reduces the pressure during wakeful periods.

Intervention Type: DEVICE

Other Intervention Names

Automatic Continuous Positive Airway Pressure; Auto CPAP; ICON+ Auto; Automatic Continuous Positive Airway Pressure with SensAwake Pressure relief; ICON+ Auto with SensAwake Pressure relief; Auto CPAP with SensAwake Pressure relief

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role: collaborator

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Louis Pepin, MD

Role: PRINCIPAL_INVESTIGATOR

CHU du Grenoble

Locations

CHU Grenoble

Grenoble, , France

Countries

France

Other Identifiers

2015-000407-57

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CIA-151

Identifier Type: -

Identifier Source: org_study_id