Effects of oral appliance (SomnoDent) on sleep disordered breathing (SDB) and cardiac function in patients with heart failure (HF)

Effects of oral appliance (SomnoDent) on sleep disordered breathing (SDB) and cardiac function in patients with heart failure (HF) - Effects of oral appliance (SomnoDent) on sleep disordered breathing (SDB) and cardiac function in patients with heart failure (HF)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025731

Enrollment

Registered

2017-02-01

Start date

2017-04-01

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

Heart failure (HF) Sleep disordered breathing (SDB)

Interventions

SomnoDent (Intervention) for 3 months, over 4 hours/day Placebo (Control) for 3 months, over 4 hours/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with symptomatic chronic HF (HF diagnosis and on beta blockers over 3 months, No change in HF drugs within 2 weeks) 2) New York Heart Association (NYHA) functional class is greater than or equal to II; either heart failure with reduced ejection fraction (left ventricular ejection fraction is less than or equal to 50%) or heart failure with preserved ejection fraction (history of hospitalization due to acute decompensated heart failure or plasma BNP level is greater than or equal to 100 pg/mL) 3) coexisting SDB (AHI is greater than or equal to 10 and the percentage of central AHI per total AHI is less than or equal to 70%)

Exclusion criteria

Exclusion criteria: 1) Primary valvular heart disease 2) PCI or TAVI or cardiac surgery within 3 months

Design outcomes

Primary

Measure	Time frame
AHI or E/e' by echocardiogram (tissue Doppler image) or plasma BNP level at 3 months	—

Countries

Japan

Contacts

Public ContactTakatoshi Kasai

Juntendo University School of Medicine Department of Cardiovascular Medicine, Cardiovascular Respiratory Sleep Medicine

kasai-t@mx6.nisiq.net03-3813-3111

Outcome results

None listed

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