javalla restart trial

JRCT ID: jRCT1042240083

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: 10
• Study type: Interventional

Intervention(s)

Patients with sleep apnea complicated by atrial fibrillation with a history of CPAP dropout will be included in the study, and provisional enrollment of consenting patients will be conducted. After eligibility verification, patients who are 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 assigned order, and will wear the existing CPAP mask (Dream Wisp Nasal Mask) and javalla mask 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 will 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 allow the patient to resume CPAP therapy). If the patient wishes to resume CPAP, CPAP will be prescribed, and the patient will use the CPAP mask of his/her choice. 6-month follow-up visits (every 4 to 12 visits, as with regular CPAP patients) will be conducted only for patients prescribed CPAP to confirm CPAP adherence.

Outcome(s)

• Primary Outcome: Discomfort when wearing javalla mask and existing CPAP (Dream Wisp Nasal Mask) mask

Secondary Outcome

Outpatient CPAP mask wearing time
Resumption rate of CPAP therapy
Rate of resumption of CPAP treatment with javalla mask

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. who have been diagnosed with sleep apnea syndrome complicated with atrial fibrillation and for which CPAP has been indicated in the past
3. Patients with a history of discontinuation of CPAP treatment for any reason after newly initiating CPAP treatment for sleep apnea syndrome as reimbursed treatment in the past.
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