Evaluation of APAP With SensAwake in OSA and Insomnia Patients

Obstructive Sleep Apnea Clinical Trial

Official title:

Evaluation of APAP With SensAwake in OSA and Insomnia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721329
• Other study ID #: CIA-151
• Secondary ID: 2015-000407-57
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: March 2020

Study information

• Verified date: June 2020
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• APAP
Automatic Continuous Positive Airway Pressure
• 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.

Locations

Country	Name	City	State
France	CHU Grenoble	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare	University Hospital, Angers, University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Sleep Quality - Wake After Sleep Onset (WASO)	Amount of time spent awake after sleep onset, as measured by actigraphy	Four weeks
Secondary	Objective Sleep Quality - Total Sleep Time	Total sleep time, as measured by actigraphy - nightly average	Four weeks
Secondary	Objective Sleep Quality - Sleep Onset Latency	Time it takes to fall asleep, as measured by actigraphy - nightly average	Four weeks
Secondary	Objective Sleep Quality - Sleep efficiency	Percentage of time in bed spent asleep, as measured by actigraphy - nightly average	Four weeks
Secondary	Treatment compliance	Time spent on CPAP treatment - nightly average	Four weeks
Secondary	Subjective sleep quality - Pittsburgh Sleep Quality Index	Questionnaire	Four weeks
Secondary	Insomnia severity - Insomnia Severity Index	Questionnaire	Four weeks
Secondary	Daytime sleepiness - Epworth Sleepiness Score	Questionnaire	Four weeks
Secondary	Quality of Life - Short Form 12	Questionnaire	Four weeks
Secondary	Blood pressure	Measured by 24 hour ambulatory blood pressure	24 hours