Oral appliance for sleep disordered breathing and in patients with heart failure

Phase 4

Recruiting

• Conditions: Sleep disordered breathing (SDB), heart failure (HF); Apnea hypopnea index (AHI), Brain natrium peptide (BNP), Left ventricular ejection fraction (LVEF)

• Registration Number: JPRN-jRCTs032210655
• Lead Sponsor: Kasai Takatoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1) Male or female >=20 years old
2) NYHA functional class >=II
3) Either HFrEF (LVEF <50%) or HFpEF (history of hospitalization for ADHF or plasma BNP level >=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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea index (AHI)

Secondary Outcome Measures

Name	Time	Method
Brain natrium peptide (BNP), Left ventricular ejection fraction (LVEF), Urinary catecholamine excretion, 6 minute walk test, Health related quality of life (SF-8, MLHFQ)