Меню
Идёт набор NCT07486882

Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)

Без фазы С лечением Chronic Insomnia 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: Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I), Acoustic Resonance Therapy (ART).
Кому может быть актуально
Состояния в реестре: Chronic Insomnia Disorder. Базовые параметры: от 22 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Feasibility Pilot Comparing Acoustic Resonance Therapy (ART) to Cognitive Behavioral Therapy for Insomnia (CBT-I) for Treating Patients With Moderate to Severe Chronic Insomnia Disorder

Обзор

The purpose of this study is to compare changes in sleep quality in patients with moderate to severe insomnia, in participants randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I) arm versus those randomized to the SONU Headband Acoustic Resonance Therapy (ART) arm at end of treatment (6 weeks).

Подробное описание

This study will randomize 60 participants with moderate to severe Insomnia to one of two treatments over the course of 6 weeks: 1) a wearable device that uses Acoustic Resonance Therapy (ART) or 2) the interactive learning module - Cognitive Behavioral Therapy for Insomnia (CBT-I).

Вмешательства

  • Поведенческое Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I)
    The interactive learning module used at Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) focuses on five components: * Sleep hygiene * Stimulus control * Sleep restriction * Worry management * Relaxation training The module includes goal-setting prompts, knowledge tests, and informational videos. Participants will utilize the CCBT-I modules daily for 6 weeks.
  • Устройство Acoustic Resonance Therapy (ART)
    The basis behind the SONU Headband system is acoustic resonance therapy (ART) which is delivered through two bone conduction transducers in the headband. Participants will utilize the SONU headband to receive a 45-minute audio session of the personalized binaural beats audio every evening prior to sleep for a duration of 6 weeks.

Первичные конечные точки

  • Sleep Disturbance [Срок оценки: Baseline, 12 weeks]
  • Sleep Impairment [Срок оценки: Baseline, 12 weeks]

Критерии участия

Критерии включения

  • Adult subjects, 22 years of age and older at screening
  • Moderate-to-severe insomnia disorder, as defined by the International Classification of Sleep Disorders (ICSD-3)\* and the Insomnia Severity Index (ISI) and have been diagnosed for more than three months.
  • Not pregnant by subject self-report at time of consent.
  • Have the ability to provide informed consent.
  • Have the ability to complete all aspects of this trial.
  • Have access to an iOS mobile device (iPhone X or above).
  • Have no contraindicating comorbid health condition that would interfere with the proper use of the SONU Headband system, as determined by the clinical investigators.
  • Participants who are taking sleep-aiding pills must agree to no changes to medication and dosage during the study.
  • According to the third edition of the International Classification of Sleep Disorders (ICSD-3), insomnia is characterized by difficulty in either initiating sleep, maintaining sleep continuity, or poor sleep quality

Критерии исключения

  • Patients who are unable to commit to avoiding the consumption of alcohol during the study.
  • Patients who are unable to commit to avoid consumption of caffeine after 12 pm (noon).
  • Patients who have a clinically significant or unstable medical or surgical condition.
  • Participants using pacemakers or cardiac monitors.
  • Participants with severe physical illness or immediately post-surgery
  • Participants with severe mental disorders, such as schizophrenia, severe major depression, severe anxiety, bipolar disorder, dementia, substance use disorder, or severe neurological diseases such as a seizure, stroke, or Parkinson's disease.
  • Participants with other serious sleep disorders, such as severe obstructive sleep apnea.
  • Participants who are unable to attend regular follow-up evaluations.
  • Any unstable medical or mental health condition as determined by the physician investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT07486882 · 24-008043

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗