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

JRCT ID: jRCTs032210509

Registered date:23/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: obstructive sleep apnea syndrome
• Date of first enrollment: 06/01/2022
• Target sample size: 60
• Study type: Interventional
• Intervention(s): The subjects should be hospitalized for 4 days, and a Sleep Evaluation Device and Low-Frequency Therapy Equipment are set from bedtime to waking up. Day 1, 2 is used only a Sleep Evaluation Device. Day 3 is method for adding Low-Frequency Therapy Equipment (3 days total trial).

Outcome(s)

• Primary Outcome: When used Low-Frequency Therapy Equipment versus not used, each case weighed the impact on REI/ODI calculated from a Sleep Evaluation Device. Day 1, 2 is not used, and Day 3 sleep is used Low-Frequency Therapy Equipment. The intended subjects are Day 2 REI 40 or more, Primary Outcomes are used Low-Frequency Therapy Equipment. The improvement cases define the availability as 50% or more than Day 2 REI, or 25% or more than Day 2 ODI.

Secondary Outcome

1)REI/ODI improvement rate when Day 2 REI is more than 20 but less than 40%.
2)REI/ODI improvement rate when Day 2 REI is more than 5 but less than 40%.
3)REI/ODI improvement rate when Day 2 REI is more than 20 but less than 50%.
4)A hypnic headache attack in morning, a subjective symptom about wake after sleep onset (Day 1, Day 2, Day 3)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Fukase Hiroyuki
• Source(s) of Monetary Support: MaRI.Co.,Ltd.,PoC Ground Tokyo