Exploratory clinical research on therapeutic effect of low-frequency sound stimulation device for obstructive sleep apnea - MARI21001

Fukase Hiroyuki0 sites60 target enrollmentDecember 23, 2021

Conditionsobstructive sleep apnea syndrome

Overview

Phase: N/A
Intervention: Not specified
Conditions: obstructive sleep apnea syndrome
Sponsor: Fukase Hiroyuki
Enrollment: 60
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study is an exploratory evaluation of efficacy and safety when using a low-frequency sound stimulator. While the awakening increased when using the low frequency sound stimulator, the improvement of REI and ODI of the primary endpoints was recognized, and it is considered to be a highly safe device. Although the parameter setting of the low frequency sound stimulator is a matter for consideration, it was a useful result for advancing the development of future equipment.

Registry

who.int

Start Date

December 23, 2021

End Date

March 28, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Fukase Hiroyuki

Eligibility Criteria

Inclusion Criteria

•1\) Patient who is able to give a written consent according to an attending physician
•2\) 20 years old or over when obtaining consent
•3\)Patients with suspected OSA in any of the following criteria:
•i) Housemates often pointed out to habitual loud snoring.
•ii) Patients have been pointed out multiple times to breath\-holding during sleep.
•iii) Patients who often feel heavy drowsiness during the day, even if they think they have had enough sleep.

Exclusion Criteria

•1\) Diagnosed with central sleep apnea syndrome (CSAS)
•2\) A cardiac pacemaker in their body
•3\) Concomitant arrhythmia
•4\) Previous myocardial infarction
•5\) The aurally challenged
•6\) BMI (body\-mass index) is 32 kg/m^2 or more
•7\) Upper limb prosthesis users
•8\) Pregnancy or Lactation
•9\) Taking drugs affecting sleep and wakefulness
•10\) Uncontrolled blood pressure even when pharmacotherapy (systolic blood pressure overed 160 mmHg or diastolic blood pressure overed 100 mmHg)