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javalla restart trial

Prospective Interventional Study to Test Whether Use of javalla Can Improve CPAP Adherence in Patients with Sleep Apnea Syndrome Complicated by Atrial Fibrillation with a History of CPAP Dropout

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042240083
Enrollment
10
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

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 el
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. 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.

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 (Dream Wisp Nasal Mask) mask

Secondary

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

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