Obstructive Sleep ApneaNCT03294629
The Effectiveness of SensAwake™ for Continue Positive Airway Pressure Treatment of Obstructive Sleep Apnea Patients
A study testing SensAwake™ modification in people with Obstructive Sleep Apnea, run by Chang Gung Memorial Hospital.
Trial summary
This study will investigate Obstructive Sleep Apnea (OSA) and an automatically Adjusting Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires experimental confirmation in a randomised controlled trial with crossover design, comparing compliance on standard APAP with compliance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- SensAwake™ modification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 1. Participants will be recruited from OSA patients who will remove CPAP himself without any notable reasons.
Who cannot join
- Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
- Inability to tolerate CPAP due to nasal obstruction or claustrophobia as determined by the study investigator.
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.
- Any known factor that result in mask taken of such as skin discomfort, nasal obstruction, water dripping inside the tubing system etc.
About this study
Official title: Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons During Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy
This study will investigate Obstructive Sleep Apnea (OSA) and an automatically Adjusting Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires experimental confirmation in a randomised controlled trial with crossover design, comparing compliance on standard APAP with compliance using APAP modified by the addition of the SensAwake™ modification on consecutive nights in participants with moderate-to-severe OSA.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- SensAwake™ modification
- Keywords
- cPAP, SenseAwake
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SensAwake™ modificationDevice
SensAwake™ is a new design based on the research of Doctor Ayappa 5 years ago. The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep.
| Study group | Role | What they receive |
|---|---|---|
| APAP begins without SensAwake | No intervention | Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks. |
| APAP begins with SensAwake | Experimental | Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks.
SensAwake™ modification: SensAwake™ is a new design based on the research of Doctor Ayappa 5 years ago. The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep. Receives: Device: SensAwake™ modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of Auto-CPAP Therapy
Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.
Measured: 2 weeks
Secondary outcomes (11)
Average SA Detections
Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)
Measured: 2 weeks
Average Pressures of Auto-CPAP Machine
Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)
Measured: 2 weeks
90th Percentile Pressures of Auto-CPAP Machine
90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Measured: 2 weeks
Average Leaks of Auto-CPAP Machine
Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Measured: 2 weeks
90th Percentile Leaks of Auto-CPAP Machine
Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Measured: 2 weeks
Residual Apnea-Hypopnea Index (AHI)
Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy.
Measured: 2 weeks
Time Used of Auto-CPAP Machine
Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Measured: 2 weeks
Percentage of Day Used of Auto-CPAP Machine
Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Measured: 2 weeks
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 2 weeks
Epworth Sleepiness Score (ESS)
The ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness.
Measured: 2 weeks
Nasal Obstruction Symptom Evaluation (NOSE)
The Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Li-Pang Chuang, MD, Principal investigator, ChangGungMemorialHospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294629
- Sponsor's protocol ID
- 103-7083B
- Status last verified
- Jun 2017
- First submitted
- 5 Aug 2015
- Last updated
- 12 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons During Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy
- ClinicalTrials.gov ID
- NCT03294629
- Acronym / sponsor ID
- 103-7083B
- Conditions
- Obstructive Sleep Apnea
- Keywords
- cPAP, SenseAwake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Posted 12 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate Obstructive Sleep Apnea (OSA) and an automatically Adjusting Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires experimental confirmation in a randomised controlled trial with crossover design, comparing compliance on standard APAP with compliance using APAP modified by the addition of the SensAwake™ modification on consecutive nights in participants with moderate-to-severe OSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APAP begins without SensAwake | No intervention | –Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks. |
| APAP begins with SensAwake | Experimental | Device: SensAwake™ modificationPatients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks. SensAwake™ modification: SensAwake™ is a new design based on the research of Doctor Ayappa 5 years ago. The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Participants will be recruited from OSA patients who will remove CPAP himself without any notable reasons.
Key exclusion criteria (4 listed)
- Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
- Inability to tolerate CPAP due to nasal obstruction or claustrophobia as determined by the study investigator.
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.
- Any known factor that result in mask taken of such as skin discomfort, nasal obstruction, water dripping inside the tubing system etc.
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 |
|---|---|---|
| SensAwake™ modificationSensAwake™ is a new design based on the research of Doctor Ayappa 5 years ago. The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep. | Device | APAP begins with SensAwake |
Primary outcome
Compliance of Auto-CPAP Therapy
Time frame: 2 weeks
Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.
11 secondary outcomes
Average SA Detections
Time frame: 2 weeks
Average Pressures of Auto-CPAP Machine
Time frame: 2 weeks
90th Percentile Pressures of Auto-CPAP Machine
Time frame: 2 weeks
Average Leaks of Auto-CPAP Machine
Time frame: 2 weeks
90th Percentile Leaks of Auto-CPAP Machine
Time frame: 2 weeks
Residual Apnea-Hypopnea Index (AHI)
Time frame: 2 weeks
Time Used of Auto-CPAP Machine
Time frame: 2 weeks
Percentage of Day Used of Auto-CPAP Machine
Time frame: 2 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 2 weeks
Epworth Sleepiness Score (ESS)
Time frame: 2 weeks
Nasal Obstruction Symptom Evaluation (NOSE)
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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RecruitingObservational study
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RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Li-Pang Chuang, MD principal investigator
ChangGungMemorialHospital
Questions about this trial
What is this clinical trial studying?
A study testing SensAwake™ modification in people with Obstructive Sleep Apnea, run by Chang Gung Memorial Hospital.
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 1 inclusion and 4 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 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 12 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Compliance of Auto-CPAP Therapy (time frame: 2 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 12 Jun 2018.