The safety and efficacy of ALARM-TD-V1 for sleep-disordered breathing

JRCT ID: jRCT2052230034

Registered date:08/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Obstructive Sleep Apnea Syndrome
• Date of first enrollment: 20/06/2023
• Target sample size: 40
• Study type: Interventional

Intervention(s)

When a signal suggestive of apnea/hypopnea is detected in a sleeping subject, a device (ALARM-TD-V1) that emits low-frequency sound is used to perform treatment during nighttime sleep.
The patient will be hospitalized for two nights and three days. the sleep evaluation device and ALARM-TD-V1 are set from bedtime to wake-up.
Patients are assigned to two groups.
One group uses only the sleep evaluation device on day 1 and ALARM-TD-V1 in addition to the sleep evaluation device on day 2.
Another group uses the sleep evaluation device and ALARM-TD-V1 on day 1 and the sleep evaluation device alone on day 2.

Outcome(s)

• Primary Outcome: AHI (apnea hypopnea index)

Secondary Outcome

1) Frequency and severity of adverse events and adverse reactions
2) ODI (oxygen desaturation index)
3) duration of oxygen desaturation
4) Presence or absence of subjective symptoms of headache upon awakening
5) Presence or absence of subjective symptoms of awakening in the middle of the night
6) Impressions of sleep by the patient
7) Patient impression of sound
8) AHI (Medicare)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

Patients who meet all of the following inclusion criteria are eligible.
1) Patients aged between 18 and 90 at the time of informed consent
2) Patients who may be indicated for treatment obstructive sleep apnea syndrome, whose oxygen desaturation index (ODI) exceeds 5 times/hour based on 3% or Patients with obstructive sleep apnea syndrome who are on CPAP therapy and consent to discontinue CPAP 7 days before Day1(including patients who have received CPAP therapy even once in the past 5 years)
3) Patients without hearing impairment: Specifically, they must be able to recognize low-frequency sounds emitted from speakers without wearing hearing aids (implantable hearing aids can be worn). Specifically, the speaker should be placed 50 cm away from the head and the sound should be audible. (Similar to the hearing test, the test is conducted by asking participants to raise their hand when they hear a sound. The sound must be played twice. When the sound is heard, the hand must be raised in succession. Those who cannot answer correctly twice in a row are excluded. becomes)
4) Patients who have given written informed consent

Exclude criteria

Patients meeting any one of the following exclusion criteria are not eligible.
1) Patients with a cardiac pacemaker
2) Patients wearing prostheses
3) Patients with fatal arrhythmia (except when the symptoms are stable due to pacemaker or ICD (implantable cardioverter-defibrillator) placement or drug treatment)
4) Patients with severe cardiac dysfunction or symptoms of heart failure (NYHA class II or higher)
5) Patients with a BMI greater than 32
6) Patients taking drugs that may alter consciousness, breathing pattern, or sleep structure (see "7.2 Concomitant drugs")
7) Pregnant women, women who may be pregnant, or women who do not intend to use contraception from obtaining consent until the end of the study period
8) Patients participating in other clinical trials
9) Other patients judged to be inappropriate by the investigator or subinvestigator

Related Information

• Primary Sponsor: Sato Susumu
• Source(s) of Monetary Support: New Energy and Industrial Technology Development Organization,Mari Co.,Ltd.