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The Effectiveness of SensAwake™ for Continue Positive Airway Pressure Treatment of Obstructive Sleep Apnea Patients

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SensAwake™ modification
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring cPAP, SenseAwake

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Participants will be recruited from OSA patients who will remove CPAP himself without any notable reasons.

Exclusion Criteria:

  1. Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
  2. Inability to tolerate CPAP due to nasal obstruction or claustrophobia as determined by the study investigator.
  3. 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.
  4. Any known factor that result in mask taken of such as skin discomfort, nasal obstruction, water dripping inside the tubing system etc.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    APAP begins without SensAwake

    APAP begins with SensAwake

    Arm Description

    Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Average SA Detections
    Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)
    Average Pressures of Auto-CPAP Machine
    Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)
    90th Percentile Pressures of Auto-CPAP Machine
    90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
    Average Leaks of Auto-CPAP Machine
    Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
    90th Percentile Leaks of Auto-CPAP Machine
    Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
    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.
    Time Used of Auto-CPAP Machine
    Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
    Percentage of Day Used of Auto-CPAP Machine
    Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
    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.
    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.
    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.

    Full Information

    First Posted
    August 5, 2015
    Last Updated
    May 11, 2018
    Sponsor
    Chang Gung Memorial Hospital
    Collaborators
    Fisher and Paykel Healthcare
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03294629
    Brief Title
    The Effectiveness of SensAwake™ for Continue Positive Airway Pressure Treatment of Obstructive Sleep Apnea Patients
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (Actual)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital
    Collaborators
    Fisher and Paykel Healthcare

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 using APAP modified by the addition of the SensAwake™ modification on consecutive nights in participants with moderate-to-severe OSA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea
    Keywords
    cPAP, SenseAwake

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    APAP begins without SensAwake
    Arm Type
    No Intervention
    Arm Description
    Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks.
    Arm Title
    APAP begins with SensAwake
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    SensAwake™ modification
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Compliance of Auto-CPAP Therapy
    Description
    Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Average SA Detections
    Description
    Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)
    Time Frame
    2 weeks
    Title
    Average Pressures of Auto-CPAP Machine
    Description
    Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)
    Time Frame
    2 weeks
    Title
    90th Percentile Pressures of Auto-CPAP Machine
    Description
    90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
    Time Frame
    2 weeks
    Title
    Average Leaks of Auto-CPAP Machine
    Description
    Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
    Time Frame
    2 weeks
    Title
    90th Percentile Leaks of Auto-CPAP Machine
    Description
    Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
    Time Frame
    2 weeks
    Title
    Residual Apnea-Hypopnea Index (AHI)
    Description
    Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy.
    Time Frame
    2 weeks
    Title
    Time Used of Auto-CPAP Machine
    Description
    Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
    Time Frame
    2 weeks
    Title
    Percentage of Day Used of Auto-CPAP Machine
    Description
    Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
    Time Frame
    2 weeks
    Title
    Pittsburgh Sleep Quality Index (PSQI)
    Description
    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.
    Time Frame
    2 weeks
    Title
    Epworth Sleepiness Score (ESS)
    Description
    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.
    Time Frame
    2 weeks
    Title
    Nasal Obstruction Symptom Evaluation (NOSE)
    Description
    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.
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Participants will be recruited from OSA patients who will remove CPAP himself without any notable reasons. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Li-Pang Chuang, MD
    Organizational Affiliation
    ChangGungMemorialHospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effectiveness of SensAwake™ for Continue Positive Airway Pressure Treatment of Obstructive Sleep Apnea Patients

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