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

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ClinicalTrials.gov Identifier: NCT03294629
Recruitment Status : Completed
First Posted : September 27, 2017
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: SensAwake™ modification Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
No Intervention: APAP begins without SensAwake
Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks.
Experimental: APAP begins with SensAwake

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.

 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Average SA Detections [ Time Frame: 2 weeks ]
    Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)

  2. Average Pressures of Auto-CPAP Machine [ Time Frame: 2 weeks ]
    Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)

  3. 90th Percentile Pressures of Auto-CPAP Machine [ Time Frame: 2 weeks ]
    90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)

  4. Average Leaks of Auto-CPAP Machine [ Time Frame: 2 weeks ]
    Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)

  5. 90th Percentile Leaks of Auto-CPAP Machine [ Time Frame: 2 weeks ]
    Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)

  6. Residual Apnea-Hypopnea Index (AHI) [ Time Frame: 2 weeks ]
    Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy.

  7. Time Used of Auto-CPAP Machine [ Time Frame: 2 weeks ]
    Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)

  8. Percentage of Day Used of Auto-CPAP Machine [ Time Frame: 2 weeks ]
    Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)

  9. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 2 weeks ]
    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.

  10. Epworth Sleepiness Score (ESS) [ Time Frame: 2 weeks ]
    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.

  11. Nasal Obstruction Symptom Evaluation (NOSE) [ Time Frame: 2 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294629


Sponsors and Collaborators
Chang Gung Memorial Hospital
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Li-Pang Chuang, MD ChangGungMemorialHospital
More Information
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03294629    
Other Study ID Numbers: 103-7083B
First Posted: September 27, 2017    Key Record Dates
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018
Last Verified: June 2017
Keywords provided by Chang Gung Memorial Hospital:
cPAP
SenseAwake
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases