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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032210509
Enrollment
60
Registered
2021-12-23
Start date
2022-01-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obstructive sleep apnea syndrome

Interventions

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. D

Sponsors

Fukase Hiroyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Contacts

Public ContactAyaka Tsukada

Clinical Research Hospital Tokyo

ayaka.tsukada@crht.jp+81-3-3355-2822

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026