Study of Sleep Quality and Its Specific Determinants During the Care Pathway of a Liver Transplant Patient

Обзор

In the LIVERSLEEP study, investigators provide an overview of sleep disorders among patients in a liver transplantation (LT) pathway and a description of the criteria that can influence their sleep. This is a prospective longitudinal monocentric pilot study, generating hypotheses whose main objective is to describe the evolution of sleep quality in LT patients between pre-LT evaluation (PLTE) and 6 months post-LT. The secondary objective(s) are, before LT, 2 months and 6 months after, (1) to describe the level of anxiety in our patients, (2) to estimate the proportion of patients with impaired sleep quality, and (3) to describe the characteristics of our patients' sleep. This study will cover all adult patients on the LT waiting list at the Croix Rousse Hospital transplant center for the duration of the study. The duration of the inclusion period is 18 months. For each patient, the participation period will be 1 year on average (pre-LT measurement with an average waiting time of 6 months for LT, then measurements at TH+2 months and at TH+ 6 months). The total duration of the study will be 30 months, with a theoretical start of inclusions in the third quarter of 2026. Patients likely to participate in the study will be identified by the transplant nurse coordinatoir (TNC) within the digestive surgery and LT department of the Croix-Rousse hospital in Lyon. These are all the patients seen in hepatology consultation for the announcement of a LT project. Verification of the selection or contraindication criteria will be carried out by the principal investigator. During the consultation with the hepatologist and the TNC to announce the indication for LT, the study will be presented by the physician and then detailed by the TNC (objectives, steps, submission of upcoming questionnaires). After collecting the patient's non-opposition, clinical data will be collected (weight, height, BMI, sex, age, indication, MELD score, and presence or absence of hepatic encephalopathy). Given the emotional burden of this consultation, no questionnaire will be submitted to the patient at this stage. During the PLTE, then 2 months and 6 months after LT, 5 questionnaires will need to be completed by the patient (evaluation of sleep quality, anxiety, chronotype, physical activity, and pain). The TNC also collects the presence of psychotropic treatments that can influence sleep. A sleep schedule will be sent to the patient with their appointment for the PLTE and to be completed before hospitalization. This diary will be retrieved during the PLTE by the TNC. The presence or absence of psychotropic treatment will also be recorded. Two and six months after the LT, during follow-up visits in ambulatory care, conventional hospitals, or consultations, the patient responds again to these five questionnaires on a tablet, and the TNC also collects the presence of psychotropic treatment. Finally, at a distance from the LT (2 months later), the TNC collects the duration of the patient's transplant wait (from the date of activation on the waiting list to the LT date), the number of examinations performed during the PLTE, and post-LT complications (return to the operating room, stent-like endovascular treatment, drain adhered to the skin), the duration of the PLTE (date of the first PLTE examination on the date of activation on the waiting list) and the immediate post-LT hospitalization period (in days). A comparative analysis will be conducted between patients whose sleep quality is altered and those for whom it is maintained, with some factors of interest related to the patient's clinic and care pathway. The results will serve as a basis for the implementation of a relevant intervention aimed at treating and reducing sleep disorders in our patients.

Первичные конечные точки

• Score of Pittsburgh Sleep Quality Index (PSQI) scale [Срок оценки: During the Pre-LiverTransplantation Evaluation, then at 2 and 6 months after LiverTransplantation.]

Критерии участия

Критерии включения

• Patients of legal age (age ≥ 18 years)
• Patients with a liver transplantation indication during the study period
• Patients who were informed and did not object to their participation in the study
• Patients affiliated with a social security scheme or beneficiaries of a similar scheme

Критерии исключения

• Patients with organ failures whose liver transplantation indication is carried during hospitalization in critical care (very short time between the indication and liver transplantation, causes of medical failure mainly related to the patient's death)
• Patients with an indication for multi-organ transplantation
• Narcolepsy
• Persons deprived of liberty by a judicial or administrative decision
• People receiving psychiatric care
• Persons admitted to a health or social welfare institution for purposes other than research
• Adults subject to a legal protection measure (guardianship, curatorship)
• Inability to understand the information regarding the protocol

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Service de chirurgie digestive et de transplantation hépatique, Hôpital de la Croix-Rousse — Lyon

Идентификаторы

NCT: NCT07674355 · 69HCL26-0229

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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