An investigator-initiated clinical trial evaluating the safety and efficacy of ALARM-TD-V2A for sleep-disordered breathing.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052250173

Enrollment

Registered

2025-12-23

Start date

2026-01-21

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Obstructive sleep apnea Obstructive sleep apnea

Interventions

During sleep in patients with obstructive sleep apnea, respiratory status will be monitored using a microphone-based respiratory state detection device and a millimeter wave radar module based respira

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients aged 18 to 90 years, inclusive, at the time of consent. 2) Patients with obstructive sleep apnea (OSA) for whom treatment may be indicated, defined as an oxygen desaturation index (ODI) using a 3% desaturation threshold of >5 events/hour; or patients with OSA currently receiving CPAP who agree to discontinue CPAP from 7 days prior to Day 1, including those who have received CPAP at any time within the past 5 years. 3) Patients who provide written informed consent.

Exclusion criteria

Exclusion criteria: Patients with a cardiac pacemaker. Patients using prosthetic or orthotic devices. Patients with life-threatening arrhythmias (except when symptoms are stably controlled by pacemaker or ICD implantation or by pharmacotherapy). Patients with severe cardiac dysfunction or heart failure symptoms corresponding to NYHA Class II or higher. Patients with BMI more than 32. Patients taking medications that may alter consciousness, respiratory pattern, or sleep architecture. Pregnant women, women who may currently be pregnant, or women who do not intend to use contraception from the time of consent through the end of the Specified Clinical Research period. Patients currently participating in another clinical trial. Any other patients deemed inappropriate for participation by the principal investigator or sub-investigator.

Design outcomes

Primary

Measure	Time frame
AHI (apnea hypopnea index, AASM)	—

Secondary

Measure	Time frame
1) Frequency and severity of adverse events and adverse reactions 2) Oxygen desaturation index (ODI) 3) Duration of oxygen desaturation episodes 4) Presence/absence of self-reported morning headache 5) Presence/absence of self-reported nocturnal awakenings 6) Patient-reported impression of sleep quality 7) Patient-reported impression of the vibration stimulus 8) Patient-reported impression of the investigational medical device 9) AHI (Medicare)	—

Measure

Time frame

1) Frequency and severity of adverse events and adverse reactions 2) Oxygen desaturation index (ODI) 3) Duration of oxygen desaturation episodes 4) Presence/absence of self-reported morning headache 5) Presence/absence of self-reported nocturnal awakenings 6) Patient-reported impression of sleep quality 7) Patient-reported impression of the vibration stimulus 8) Patient-reported impression of the investigational medical device 9) AHI (Medicare)

—

Contacts

Public ContactHironobu Sunadome

Graduateschool of Medicine, Kyoto University

sankichi@kuhp.kyoto-u.ac.jp+81-757513852

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026