javalla exchange trial

JRCT ID: jRCT1042240082

Registered date:04/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sleep apnea syndrome, atrial fibrillation
• Date of first enrollment: 06/09/2024
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Provisional enrollment of patients with sleep apnea indicated for CPAP treatment with concomitant atrial fibrillation during CPAP treatment will be conducted for those cases in which consent is obtained. After eligibility verification, patients who are confirmed to be eligible will be enrolled and assigned to the study.
Patients will be assigned to CPAP in the outpatient consultation room of the department in the order they are assigned, and the CPAP mask currently in use and the javalla mask will be applied for 10 minutes each. If the patient is unable to continue wearing the mask for 10 minutes due to discomfort or other reasons, early discontinuation of CPAP may be permitted. A quantitative evaluation of discomfort will be conducted by VAS immediately after the end of each session. A questionnaire will be administered at the end of the intervention (e.g., which mask would the patient prefer to use for CPAP therapy at home).
The javalla masks will continue to be loaned to the patients, and CPAP treatment will be continued for one month at a time in the order assigned. Early discontinuation will be allowed if the patient is unable to continue using the mask for one month due to discomfort or other reasons. Immediately after the end of each period of use, a quantitative evaluation of discomfort will be performed using the VAS. A questionnaire survey will be administered at the end of the intervention (e.g., whether the patient would like to switch from the current mask to javalla).

Outcome(s)

• Primary Outcome: Discomfort when wearing javalla mask and existing CPAP mask

Secondary Outcome

Outpatient mask wearing time
Various parameters of CPAP report (days of use, days of use over 4 hours, AHI, large leak, average pressure, maximum pressure)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria are eligible
1. 18 years of age or older
2. Patients with atrial fibrillation and previously diagnosed sleep apnea with indication for CPAP
3. Patients who have been introduced to CPAP therapy and are currently continuing CPAP therapy.
4. Persons who have consented to participate in this study by signing a consent form in person.

Exclude criteria

1. those with dementia or other conditions that make it difficult for them to wear a mask or use a CPAP device on their own
2. who have nasal obstruction requiring treatment
3. women who are pregnant or have the possibility of pregnancy
4. Other persons who are judged by the principal investigator or subinvestigator to be ineligible for participation in this study.

Related Information

• Primary Sponsor: Naruse Yoshihisa