NCT02721329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

3.8 years

First QC Date

March 23, 2016

Last Update Submit

June 30, 2020

Conditions

Obstructive Sleep ApneaInsomnia

Keywords

Obstructive Sleep ApneaOSAInsomniaCPAPSensAwake

Outcome Measures

Primary Outcomes (1)

  • Objective Sleep Quality - Wake After Sleep Onset (WASO)

    Amount of time spent awake after sleep onset, as measured by actigraphy

    Four weeks

Secondary Outcomes (9)

  • Objective Sleep Quality - Total Sleep Time

    Four weeks

  • Objective Sleep Quality - Sleep Onset Latency

    Four weeks

  • Objective Sleep Quality - Sleep efficiency

    Four weeks

  • Treatment compliance

    Four weeks

  • Subjective sleep quality - Pittsburgh Sleep Quality Index

    Four weeks

  • +4 more secondary outcomes

Study Arms (2)

APAP without SensAwake

ACTIVE COMPARATOR

Auto CPAP delivered from the ICON+ CPAP device.

Device: APAP

APAP with SensAwake

EXPERIMENTAL

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.

Device: APAP with SensAwake

Interventions

APAPDEVICE

Automatic Continuous Positive Airway Pressure

Also known as: Automatic Continuous Positive Airway Pressure, Auto CPAP, ICON+ Auto
APAP without SensAwake
APAP with SensAwakeDEVICE

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.

Also known as: Automatic Continuous Positive Airway Pressure with SensAwake Pressure relief, ICON+ Auto with SensAwake Pressure relief, Auto CPAP with SensAwake Pressure relief
APAP with SensAwake

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble

Grenoble, France

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Jean-Louis Pepin, MD

    CHU du Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

March 29, 2016

Study Start

June 1, 2016

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

July 2, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)