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

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294629
• Other study ID #: 103-7083B
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2017
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Fisher and Paykel Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Secondary	Average SA Detections	Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)	2 weeks
Secondary	Average Pressures of Auto-CPAP Machine	Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)	2 weeks
Secondary	90th Percentile Pressures of Auto-CPAP Machine	90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)	2 weeks
Secondary	Average Leaks of Auto-CPAP Machine	Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)	2 weeks
Secondary	90th Percentile Leaks of Auto-CPAP Machine	Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)	2 weeks
Secondary	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.	2 weeks
Secondary	Time Used of Auto-CPAP Machine	Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)	2 weeks
Secondary	Percentage of Day Used of Auto-CPAP Machine	Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)	2 weeks
Secondary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	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.	2 weeks