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NCT04653883: Pro-TSIC
Prognostic Impact of Sleep Disorders in Patients : Pro-TSIC Study
trial in Heart Failure in 115 participants. Completed in 1 December 2020.
30 September 2020
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 115 |
| Start date | 1 June 2020 |
| Primary completion | 30 September 2020 |
| Estimated completion | 1 December 2020 |
| Sites | 1 location across France |
Conditions studied
- Heart Failure — all drugs for Heart Failure →
- Sleep Disorder — all drugs for Sleep Disorder →
- Insomnia — all drugs for Insomnia →
Sponsor
University Hospital, Montpellier
Who can join
Adults 30 to 90, any sex, with Heart Failure or Sleep Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Prognostic Impact of Sleep Patterns and Related-Drugs in Patients with Heart Failure.
Bughin F, Jaussent I, Ayoub B, Aguilhon S, et al · · 2021 · cited 2× · PMID 34830668 · DOI 10.3390/jcm10225387
Verify or expand the search:
- PubMed search for NCT04653883
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other University Hospital, Montpellier trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04653883 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
- Last refreshed: 29 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04653883.
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