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

Prognostic Impact of Sleep Disorders in Patients With Heart

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04653883
Acronym
Pro-TSIC
Enrollment
115
Registered
2020-12-04
Start date
2020-06-01
Completion date
2020-12-01
Last updated
2020-12-29

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

Conditions

Heart Failure, Insomnia, Sleep Disorder

Brief summary

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.

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\- age less than 30 years

Design outcomes

Primary

MeasureTime frameDescription
To study the occurrence of cardiovascular events, whether fatal or not, according to the presence or absence of sleep or wakefulness disorders1 daycomposite endpoint including mortality from any cause, hospitalization forrom any cardiovascular eventscause, heart transplantation and implantation of a defibrillator or circulatory assistance

Secondary

MeasureTime frameDescription
Evaluate the occurrence of fatal events according to the presence or absence of sleep or wakefulness disorders1 dayEvaluate the occurrence of fatal events according to the presence or absence of sleep or wakefulness disorders
Evaluate the occurrence of cardiovascular non-fatal major adverse cardiovascular events according to the presence or absence of sleep or wakefulness disorders1 dayEvaluate the occurrence of cardiovascular non-fatal major adverse cardiovascular events according to the presence or absence of sleep or wakefulness disorders
Evaluate the occurrence of fatal or non-fatal major adverse cardiovascular events depending on whether or not medication is taken for sleep disorders1 dayEvaluate the occurrence of fatal or non-fatal major adverse cardiovascular events depending on whether or not medication is taken for sleep disorders

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026