Sleep disordered breathing (SDB), heart failure (HF) Apnea hypopnea index (AHI), Brain natrium peptide (BNP), Left ventricular ejection fraction (LVEF)
Conditions
Interventions
Sponsors
Kasai Takatoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female >=20 years old 2) NYHA functional class >=II 3) Either HFrEF (LVEF =100 pg/mL or serum NT-proBNP level >=400 pg/mL) 4) Coexisting SDB (AHI of >=10 and percentage of central AHI per total AHI of <=70%) 5) Ability of attaching/detaching oral appliance 6) the use of beta blocker for more than 3 months and no change in medication within 2 weeks 7) the follow-up PSG is scheduled in registration 8) Craniofacial X-ray (cephalogram) and CT are scheduled in registration
Exclusion criteria
Exclusion criteria: 1) Insufficient teeth for splint retention 2) Evidence of active periodontal disease or dental caries 3) Change in HF drugs in 2 weeks 4)ACS (including STEMI, non-STEMI, and unstable angina) 5)Cardiac surgery (open heart surgery) within 3 months 6)Severe valvular heart disease 7) Life-threatening malignancy 8) COPD with oxygen inhalation 9) End-stage renal disease 10) Pregnancy 11) Occupational driver
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnea-hypopnea index (AHI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Brain natrium peptide (BNP), Left ventricular ejection fraction (LVEF), Urinary catecholamine excretion, 6 minute walk test, Health related quality of life (SF-8, MLHFQ) | — |
Contacts
Public ContactTakatoshi Kasai
Juntendo University Hospital
Outcome results
None listed