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

NCT03294629 | Completed Results DMC

• 1 other identifier: 103-7083B
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea

Keywords

cPAP; SenseAwake

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Average SA Detections

  2 weeks

• Average Pressures of Auto-CPAP Machine

  2 weeks

• 90th Percentile Pressures of Auto-CPAP Machine

  2 weeks

• Average Leaks of Auto-CPAP Machine

  2 weeks

• 90th Percentile Leaks of Auto-CPAP Machine

  2 weeks

Study Arms (2)

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.

Device: SensAwake™ modification

Interventions

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.

APAP begins with SensAwake

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Fisher and Paykel Healthcare: collaborator

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ning-Hung, Chen
• Organization: Sleep Center, Taoyuan Chang Gung Memorial Hospital

ninghung@yahoo.com.tw

+886-3-3281200

Study Officials

• Li-Pang Chuang, MD

  ChangGungMemorialHospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: September 27, 2017
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 12, 2018
• Results First Posted: June 12, 2018

Record last verified: 2017-06