Prognostic Impact of Sleep Disorders in Patients : Pro-TSIC Study

NCT ID: NCT04653883

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-12-01

Brief Summary

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Heart failure (HF) is a common and progressive condition associated with significant morbidity and mortality. Only 25-35% of patients survive 5 years after diagnosis.Sleep disorders are frequently found in this population with up to 94% of patients complaining of sleep disorders. Of these, insomnia and sleep disorders are the most common. The frequency of restless legs syndrome (RLS) varies between 4 and 40% depending on the studies. Patients with HF frequently experience poor sleep quality which is associated with deterioration in quality of life, alertness, and mood.

Few studies have examined the prognostic impact of sleep disturbances in this population. A greater morbidity and mortality is observed in the event of poor quality sleep or in the presence of sleep breathing disorders .

The investigators therefore propose to evaluate the sleep disorders of patients with HF by self-administered questionnaires, hypothesizing that complaints of poor sleep are linked to a poorer cardiovascular prognosis.

Detailed Description

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Conditions

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Heart Failure Sleep Disorder Insomnia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

\- heart failure according to the 2016 criteria of the European Society of Cardiology.

Exclusion Criteria

\- age less than 30 years
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François BUGHIN, PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL20_0307

Identifier Type: -

Identifier Source: org_study_id