Exploration of clinical background factors that impair sleep quality in hospitalized patients with heart failure: Objective evaluation of sleep using wearable devices

Exploration of clinical background factors that impair sleep quality in hospitalized patients with heart failure: Objective evaluation of sleep using wearable devices - The relationship between the clinical background of heart failure and the quality of sleep- A cross-sectional study using wearable devices-

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000055852

Enrollment

Registered

2024-10-17

Start date

2025-05-20

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

Interventions

Fitbit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Hospitalised patients with NYHA class II or III heart failure 2) Patients aged 18 years or over (regardless of gender) 3) Patients who can wear the Fitbit for three consecutive days during their hospital stay 4) Patients who have been given an explanation of the study and who can sign the independent clinical research consent form

Exclusion criteria

Exclusion criteria: 1) If the patient is unable to wear the Fitbit (e.g. due to allergies or interference with medical devices) 2) If there is a significant decline in cognitive function, making data collection difficult

Design outcomes

Primary

Measure	Time frame
sleep efficiency	—

Secondary

Measure	Time frame
1. Basic clinical information Age, gender, BMI, heart failure severity (NYHA classification), presence or absence of hypertension, presence or absence of dyslipidaemia, presence or absence of diabetes, presence or absence of chronic kidney disease, presence or absence of respiratory disease, smoking habits, drinking habits, medication, blood test data, physical frailty, social frailty 2. Fitbit data Sleep time, wake time, number of awakenings, time in bed, REM sleep time, light sleep time, deep sleep time, average number of steps, average distance, average heart rate per day, average respiratory rate per day, average oxygen saturation per day 3. PSQI score	—

Measure

Time frame

1. Basic clinical information Age, gender, BMI, heart failure severity (NYHA classification), presence or absence of hypertension, presence or absence of dyslipidaemia, presence or absence of diabetes, presence or absence of chronic kidney disease, presence or absence of respiratory disease, smoking habits, drinking habits, medication, blood test data, physical frailty, social frailty 2. Fitbit data Sleep time, wake time, number of awakenings, time in bed, REM sleep time, light sleep time, deep sleep time, average number of steps, average distance, average heart rate per day, average respiratory rate per day, average oxygen saturation per day 3. PSQI score

—

Countries

Japan

Contacts

Public ContactTomohiro Ishinuki

Sapporo Medical University Department of Health and Sciences

tomohiro-ishi@sapmed.ac.jp0116112111

Outcome results

None listed

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