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Идёт набор NCT06155916

Sleep and Neuropathic Pain - Intervention Study on Pregabalin

Без фазы С лечением Neuropathic Pain Insomnia Sleep Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pregabalin.
Кому может быть актуально
Состояния в реестре: Neuropathic Pain, Insomnia, Sleep Disorder. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Финляндия
Следующий шаг
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Официальное название

Sleep Structure in Neuropathic Pain Patients, Psychological Factors, Brain Connectivity, and the Effect of Pregabalin on Sleep and Pain

Обзор

The goal of this clinical study is to study sleep and its microstructure in neuropathic pain patients who have or who do not have a clinically significant sleep disturbance, before and during (after 1-month stabile dosage) pregabalin treatment. To find out whether reduced pain by pregabalin associates with improved sleep quality; to study, using resting state fMRI, brain network connectivity and the volume of the choroid plexus before and during pregabalin treatment (after dosage stable for one month) at baseline and during stabile treatment with pregabalin, and to compare the usability and reliability of sleep-related information collected with sleep diaries, actigraphy, iButtons, and ambulatory polysomnography in peripheral painful neuropathy patients. The main questions it aims to answer are: * Is pregabalin more efficacious in neuropathic pain patients who suffer from insomnia compared to those with no clinically meaningful sleep disturbance? * Does sleep disturbance due to pain associate with brain network connectivity and may these changes be reversed by pregabalin treatment? Participants will * Fulfill e-questionnaires and keep sleep diary before and after 1month stabile pregabalin intervention * Before and after 1-month stabile pregabalin medication: 1-week Actiwatch monitoring, iButton (1 day and night), ambulatory polysomnography (1 night), brain fMRI. Researchers will compare patients with high ISI score patients to see if they benefit more from pregabalin treatment than those with low ISI score.

Подробное описание

This is a clinical study to analyze sleep and pain and their response to pregabalin in 40 patients aged 18 to 75 years with chronic (duration\>3 months) moderate to severe pain (NRS ≥ 4/10) due to peripheral neuropathy. The investigators divide patients to two groups according to scores in ISI: the ones with clinically significant insomnia with score 15 or more (ISI High) and the ones without marked insomnia with score 14 or lower (ISI Low). Sleep will be assessed by a sleep diary, iButton, polysomnography and 1-week Actiwatch monitoring before and after 1-month stabile pregabalin dosage. Additionally, at these time points, several questionnaires regarding pain, sleep, mood, and quality of life and functional brain MRI will be performed. At pregabalin administration, the dose is added three to four day intervals, if tolerated by the patient. After a maximum tolerated dose has been stable for 1 month, the sleep studies, questionnaires, and brain fMRI are repeated. The study duration is about 3 months.

Вмешательства

  • Препарат Pregabalin
    Pregabalin administration and titration to the highest dosage that the patient tolerates. The patient continues with the highest dose for one month and the pre-intervention studies are repeated.

Первичные конечные точки

  • Pregabalin response to pain [Срок оценки: Change from baseline pain intensity and interference immediately after the intervention]
  • Pregabalin effect on sleep stages [Срок оценки: Change from baseline immediately after the intervention]
  • Sleep disturbance associations to brain network connectivity [Срок оценки: Change from baseline immediately after the intervention]
  • Sleep disturbance associations to choroid plexus volume in brain fMRI [Срок оценки: Change from baseline immediately after the intervention]
  • Pregabalin effect on circadian rhythms [Срок оценки: Change from baseline immediately after the intervention]
  • Pregabalin effect on body temperature during sleep [Срок оценки: Change from baseline immediately after the intervention]

Критерии участия

Критерии включения

  • Chronic (duration > 3 months) painful peripheral neuropathy
  • Pain moderate to severe (NRS ≥ 4/10) during the past week

Критерии исключения

  • psychotic depression, clinically significant bipolar disorder
  • contraindication for performing brain fMRI (metal in the body etc)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Финляндия · 2 центра
  • Helsinki University Central Hospital — Helsinki
  • Helsinki University Hospital, Department of Neurology — Helsinki

Идентификаторы

NCT: NCT06155916 · TYH2020214

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗