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OpenTrials
Completed

NCT Number: NCT03294629

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

SensAwake™ modification

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Fisher and Paykel Healthcare

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 27, 2017
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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