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

Not Applicable

• Conditions: obstructive sleep apnea syndrome

• Registration Number: JPRN-jRCTs032210509
• Lead Sponsor: Fukase Hiroyuki

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-23
• Study Completion: 2022-03-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

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)
11) Patients with SAS in active treatment
(ex. Continuous Positive Airway Pressure (CPAP) Therapy, using an intraoral device)
12) Tobacco smorker (1 pack or more per day)
13) Hypersensitive patients
14) Patients otherwise whom principal investigator/sub- investigator considered medically ineligible to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified