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javalla exchange trial

Prospective Interventional Study to Test Whether Use of javalla Can Improve CPAP Adherence in Patients with Sleep Apnea Complicated by Atrial Fibrillation During CPAP Therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042240082
Enrollment
20
Registered
2024-09-04
Start date
2024-09-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep apnea syndrome, atrial fibrillation Sleep apnea syndrome, atrial fibrillation, CPAP

Interventions

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 obtain
CPAP

Sponsors

Naruse Yoshihisa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Discomfort when wearing javalla mask and existing CPAP mask

Secondary

MeasureTime frame
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)

Contacts

Public ContactYoshihisa Naruse

Hamamatsu University School of Medicine

ynaruse@hama-med.ac.jp+81-534352356

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026