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

INTERVENTION: 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. CONDITION: D020181 Obstructive Sleep Apnea Syndrome ; Sleep‐disordered breathing Sleep‐disordered breathing 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) INCLUSION 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 inde X(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,