Obstructive Sleep ApneaNCT02721329
Evaluation of APAP With SensAwake in OSA and Insomnia Patients
A study testing APAP and APAP with SensAwake in people with Obstructive Sleep Apnea and Insomnia, run by Fisher and Paykel Healthcare at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Insomnia
- What is being tested?
- APAP and APAP with SensAwake
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- APAP, APAP with SensAwake
- Keywords
- Obstructive Sleep Apnea, OSA, Insomnia, CPAP, SensAwake
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APAPDevice
Also called Automatic Continuous Positive Airway Pressure, Auto CPAP, ICON+ Auto
Automatic Continuous Positive Airway Pressure
APAP with SensAwakeDevice
Also called Automatic Continuous Positive Airway Pressure with SensAwake Pressure relief, ICON+ Auto with SensAwake Pressure relief, Auto CPAP with SensAwake Pressure relief
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.
| Study group | Role | What they receive |
|---|---|---|
| APAP without SensAwake | Active comparator | Auto CPAP delivered from the ICON+ CPAP device. Receives: 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. Receives: Device: APAP with SensAwake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Sleep Quality - Wake After Sleep Onset (WASO)
Amount of time spent awake after sleep onset, as measured by actigraphy
Measured: Four weeks
Secondary outcomes (9)
Objective Sleep Quality - Total Sleep Time
Total sleep time, as measured by actigraphy - nightly average
Measured: Four weeks
Objective Sleep Quality - Sleep Onset Latency
Time it takes to fall asleep, as measured by actigraphy - nightly average
Measured: Four weeks
Objective Sleep Quality - Sleep efficiency
Percentage of time in bed spent asleep, as measured by actigraphy - nightly average
Measured: Four weeks
Treatment compliance
Time spent on CPAP treatment - nightly average
Measured: Four weeks
Subjective sleep quality - Pittsburgh Sleep Quality Index
Questionnaire
Measured: Four weeks
Insomnia severity - Insomnia Severity Index
Questionnaire
Measured: Four weeks
Daytime sleepiness - Epworth Sleepiness Score
Questionnaire
Measured: Four weeks
Quality of Life - Short Form 12
Questionnaire
Measured: Four weeks
Blood pressure
Measured by 24 hour ambulatory blood pressure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Grenoble, University Hospital, Angers
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pepin, MD, Principal investigator, CHU du Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721329
- Sponsor's protocol ID
- CIA-151
- Other IDs
- 2015-000407-57, 2015
- Status last verified
- Jun 2020
- First submitted
- 23 Mar 2016
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of APAP With SensAwake in OSA and Insomnia Patients
- ClinicalTrials.gov ID
- NCT02721329
- Acronym / sponsor ID
- CIA-151
- Conditions
- Obstructive Sleep Apnea, Insomnia
- Keywords
- Obstructive Sleep Apnea, OSA, Insomnia, CPAP, SensAwake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Grenoble, University Hospital, Angers
- Study start
- Jun 2016
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APAP without SensAwake | Active comparator | Device: APAPAuto CPAP delivered from the ICON+ CPAP device. |
| APAP with SensAwake | Experimental | Device: APAP with SensAwakeAuto 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APAPAlso: Automatic Continuous Positive Airway Pressure, Auto CPAP, ICON+ AutoAutomatic Continuous Positive Airway Pressure | Device | APAP without SensAwake |
| APAP with SensAwakeAlso: Automatic Continuous Positive Airway Pressure with SensAwake Pressure relief, ICON+ Auto with SensAwake Pressure relief, Auto CPAP with SensAwake Pressure reliefAutomatic 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. | Device | APAP with SensAwake |
Primary outcome
Objective Sleep Quality - Wake After Sleep Onset (WASO)
Time frame: Four weeks
Amount of time spent awake after sleep onset, as measured by actigraphy
9 secondary outcomes
Objective Sleep Quality - Total Sleep Time
Time frame: Four weeks
Objective Sleep Quality - Sleep Onset Latency
Time frame: Four weeks
Objective Sleep Quality - Sleep efficiency
Time frame: Four weeks
Treatment compliance
Time frame: Four weeks
Subjective sleep quality - Pittsburgh Sleep Quality Index
Time frame: Four weeks
Insomnia severity - Insomnia Severity Index
Time frame: Four weeks
Daytime sleepiness - Epworth Sleepiness Score
Time frame: Four weeks
Quality of Life - Short Form 12
Time frame: Four weeks
Blood pressure
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis Pepin, MD principal investigator
CHU du Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APAP and APAP with SensAwake in people with Obstructive Sleep Apnea and Insomnia, run by Fisher and Paykel Healthcare at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Sleep Quality - Wake After Sleep Onset (WASO) (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.