AADHERE Study

JRCT ID: jRCT1072210122

Registered date:31/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: obstructive sleep apnea syndrome
• Date of first enrollment: 14/02/2022
• Target sample size: 26
• Study type: Interventional

Intervention(s)

Randomize after confirming adherence to CPAP treatment during the run-in phase.
After the wash out period, group A will be treated with CPAP and group B will be followed up for 13 to 16 weeks. Then, after the wash out period again, group A is followed up and group B is treated with CPAP for 13 to 16 weeks.

Outcome(s)

• Primary Outcome: Mean number of atrial premature contraction (APC) obtained on a continuous electrocardiogram monitor.
• Secondary Outcome: Mean number of ventricular premature contractions (VPC) if patients who the continuous electrocardiogram monitor showed 300/day or more of VPC before the registration, urinary albumin creatinine ratio (UACR), Suppression of new arrhythmia that did not occur before the registration, nocturnal blood pressure and its fluctuation, QOL (SF-8, EQ-5D) evaluation, JESS evaluation, APC expression count during sleep or awakening,safety (incidence rate of serious adverse events)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

[At the time of temporary registration]
1) Patients aged 40 to 85 years at the time of consent.
2) Examination using pulse oximetry within 12 weeks showed a total of 0.2 minutes or more of time when SpO2 during sleep was less than 85%.
3) JESS<16.
4) Patients who the doctor has determined does not require immediate treatment for cardiovascular disease.
5) Patients who the doctor has determined does not require immediate treatment for sleepiness.
6) Patients who meet the diagnostic criteria of OSAS and have no treatment history for SAS. However, patients who are receiving CPAP treatment but have been used for less than 10% in the 12 weeks before temporary registration can be registered.
7) Written informed consent

[ At the time of registration]
1) In the run-in part, dates of CPAP treatment which was performed more than 4 hours are confirmed 10 days at least.
2) Patients who have an average of 200 or more APCs on a continuous electrocardiogram monitor within 12 weeks before the main registration and who are judged not to require arrhythmia treatment within 6 months.
3) Patients who the doctor has determined that the study can be continued.

Exclude criteria

[At the time of temporary registration]
1) Patients who wish to start SAS treatment immediately.
2) Patients on medication for arrhythmia.
3) Patients undergoing treatment for heart failure and coronary artery disease.
4) Patients with pacemaker or resynchronization therapy.
5) Patients who are strongly expected to change cardiovascular drugs within 6 months.
6) At the time of SAS diagnosis, CSR was 50% or more.
7) Patients undergoing treatment for chronic renal failure. (excluding diet and treatment for complications)
8) Patients with lung disease which may cause a decrease SpO2
9) Those who correspond to any of the following about sleepness.
i. There is a complaint of sleepiness
ii. There is an experience of near accidents or accidents because of sleepiness
iii. Occupational driver
10) Patients participating in other clinical studies at the time of consent acquisition or expected to participate in other clinical studies.
11) Subject whom the doctor judged by doctor to be ineligible for this study.

Related Information

• Primary Sponsor: Ando Shin-ichi
• Source(s) of Monetary Support: Teijin Pharma