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Italian Study on Sleep and Heart Failure

Italian Multicenter Project Sleep and Heart Failure - PROMISES: Design Multicenter Sleep and Heart Failure

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-7tmkv9
Enrollment
Unknown
Registered
2012-12-11
Start date
2012-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure, sleep respiratory disorders and quality of life.

Interventions

The objective of this study is to quantify the incidence of cardiovascular events in patients with chronic heart failure and their relation to sleep respiratory disorders. Will be invited to participa
other

Sponsors

Universidade Nove de Julho - UNINOVE
Lead Sponsor
Universidade Nove de Julho - UNINOVE
Collaborator

Eligibility

Age
19 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients with heart failure who agree to participate in the study; both gender; age between 19 and 90 years; cognitive level sufficient to understand the procedures and follow the instructions; stable clinical conditions for at least four weeks and optimized medical therapy; assigned consent form."

Exclusion criteria

Exclusion criteria: Individuals with HIV; renal failure with the calculation of filtered under 30ml/minutes; malignant neoplasm; abuse of alcohol and or drugs.

Design outcomes

Primary

MeasureTime frame
Expected to get the index and obstructive respiratory events during sleep or central, verified through the apnea/hypopnea per hour of sleep obtained by basal nocturnal polysomnography

Secondary

MeasureTime frame
Check the change in total sleep time, sleep latency, sleep stages, arousal index, abnormal sleep behavior evaluated by polysomnography nocturnal basal;Check the level of the autonomic nervous activity sympathetic and parasympathetic verified through analysis of heart rate variability during sleep;Measuring the neck circumference measured in centimeters, by means of tape, to check whether there is a relationship with the object of study;Measuring the quality of life assessed by the quality of life questionnaire SF-36 (generic questionnaire, with concepts not specific to a certain age, disease or treatment group and allows for comparisons between different diseases and different treatments;Realize that there is presence of excessive daytime sleepiness verified by Epworth Sleepiness Scale (This is a scale consisting of a series of key questions, which are widely used to see how sleep affects your daily life. You will confer as walking the likelihood of falling asleep in certain situations);To investigate the risk of obstructive sleep apnea verified by clinical questionnaire Berlin(screening instrument syndrome obstructive sleep apnea(OSA)in primary care)

Countries

Brazil

Contacts

Public ContactLuís ;Luis Vicente Oliveira;Oliveira

Universidade Nove de Julho - UNINOVE;Universidade Nove de Julho - UNINOVE

oliveira.lvf@pq.cnpq.br;oliveira.lvf@uninove.br+55(11)3665-9894;+55(11)3385-9000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)