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临床试验/NCT06631807
NCT06631807Enrolling By Invitation不适用

The Impact of the Years of Blindness on Sleep and Dreaming Processes and Possible Relationships With Spatial Abilities

Istituto Italiano di Tecnologia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
1
主要终点
Sleep macrostructure

研究概览

简要总结

This study aims to assess the impact of blindness on sleep and dreaming processes and the relationship with spatial perceptual performance, examining the link with clinical and psychological indices, neurobiological features, and electrophysiological measures.

详细描述

BLINDREAM is an observational neuropsychology study purely for scientific purposes, with no diagnostic or therapeutic aims. This study aims to assess the impact of blindness on sleep and dream processes and their relationship with perceptual and spatial memory performance, examining the connection with clinical, psychological/behavioral indices, neurobiological characteristics, and electrophysiological measures. Specifically, the study seeks to test the following hypotheses:

  • Circadian Rhythm Desynchronization: To determine if visual deprivation leads to circadian rhythm desynchronization in both congenitally blind individuals and those with late-onset blindness after many years of visual deprivation. Specifically, whether greater circadian desynchronization is associated with poorer performance in perceptual and spatial memory tasks in blind subjects.
  • Sleep Structure: To investigate if circadian desynchronization affects sleep structure in blind individuals and if it is the sole factor influencing sleep structure. We hypothesize that even blind subjects with a normally modulated circadian rhythm due to the light-dark cycle show significant differences from sighted controls, particularly in terms of sleep microstructure (figures) and macrostructure (stages) involved in sensorimotor processing and spatial information consolidation.
  • Dream Recall and Spatial Abilities: To examine if there is a significant difference in dream recall frequency and specific spatial tasks between the two groups. Specifically, whether a higher presence of visual content in dreams predicts better spatial skills, and whether increased eye movement in dreams correlates with better spatial abilities in blind subjects.

These findings will enable initial assessments that may lead to the development of new tools and rehabilitation protocols for blind individuals.

The study will be conducted in three experimental phases over a total of one week per participant:

  • Phase 1: Sleep and Dream Assessment: This includes two measures-1A. Questionnaires and 1B. Polysomnography.
  • Phase 2: Circadian Assessment: This includes three measures-2A. Actigraphy (worn for one week), 2B. Salivary melatonin analysis, and 2C. Dream diary.
  • Phase 3: Neuropsychological Assessment: This involves evaluating several conditions with two specific configurations-3A. Assessment of spatial perceptual functions and 3B. Assessment of spatial memory.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signature of the informed consent;
  • The participating subjects may have typical or atypical development (i.e., group with visual disability). In the case of visual impairment, the disability should be congenital (from birth) or late onset. Furthermore, the following requirements must be met: subjects with visual disabilities must be classified according to current diagnostic rules, with visual problems present from birth or occurring later, with residual vision lower than 1.3 LogMAR;
  • Age range required is ≥ 18 years old and ≤ 85 years old;
  • Any Gender;
  • Any ethnicity, as long as a good knowledge of the Italian language.

排除标准

  • Participant with a disability/condition/comorbidity that prevents participation and/or does not guarantee the safety of the patient during the execution of the tests and/or does not guarantee the quality/reliability of the data:
  • Tactile and/or acoustic hypersensitivity (specifically, the tolerance of the equipment will be assessed);
  • Deafness;
  • Taking drugs and neuroactive substances and having taken them in the last six months;
  • Comorbidity with another clinically significant and uncontrolled pathology;
  • Being affected, to the best of their knowledge, by pathologies of the central nervous system, and having suffered from epileptic episodes, even minor ones, and convulsive crises in general;
  • Being affected, to the best of their knowledge, by cardio-respiratory pathologies that can influence the macro and microstructure of sleep.
  • Lack of signature of consent or incomplete consent to acknowledge the incompatibilities for participation in the study;
  • To the best of their knowledge, IQ values lower than the threshold limit of normality according to one of the recognized international scales.
  • Pregnant women

结局指标

主要结局

Sleep macrostructure

时间窗: Through study completion, an average of 18 months

Percentage of sleep stages and spectrogram

Sleep microstructure

时间窗: Through study completion, an average of 18 months

Analysis of slow waves

Sleep quality - PSQI

时间窗: Through study completion, an average of 12 months

Pittsburgh Sleep Quality Index. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores indicate worse sleep quality.

Dream content evaluation - DRFS

时间窗: Through study completion, an average of 12 months

The Dream Recall Frequency Scale (DRFS) is a useful tool for assessing how often individuals remember their dreams. This scale can help distinguish between high dreamers (those who frequently recall dreams) and low dreamers (those who rarely remember dreams). The scale typically ranges from 0 to 5, where a higher value indicates more frequent recall of dreams.

Sleep Quality - questionnaire to predict N24HSWD

时间窗: Through study completion, an average of 12 months

Pre-Screening questionnaire to predict Non-24-hours sleep-wake disorders. The questionnaire assesses sleep-wake patterns, focusing on irregularities such as difficulty maintaining a regular sleep schedule and daytime dysfunction. It includes a set of eight key questions. The scoring system can yield final values greater than or less than zero: 1. Values greater than zero suggest that the patient should be evaluated for N24HSWD. 2. Values less than zero indicate the need for assessment for other sleep disorders. This tool serves as an initial filter, guiding whether further diagnostic measures, like actigraphy or melatonin rhythm analysis, are necessary

Sleep quality - MEQ

时间窗: Through study completion, an average of 12 months

Morningness -Eveningness Questionnaire. It is a Self-reported assessment of morningness and eveningness preferences with a 19 multiple choice items (4-5 point numerical scale). The sum gives a score ranging from 16 to 86; scores of 41 and below indicate "evening types", scores of 59 and above indicate "morning types", scores between 42-58 indicate "intermediate types".

Circadian shift

时间窗: Through study completion, an average of 18 months

Actigraphy measures

Spatial perception ability

时间窗: Through study completion, an average of 12 months

Spatial and temporal bisection

Spatial memory ability

时间窗: Through study completion, an average of 12 months

Audiocorsi

Dream content evaluation - VDAS

时间窗: Through study completion, an average of 12 months

The Van Dream Anxiety Scale (VDAS) is a tool used to assess the severity of nightmares and dream anxiety. The VDAS consists of a set of items that measure the frequency, intensity, and emotional impact of nightmares, as well as their interference with daily functioning. The scale typically provides a range of scores from 0 to 68, where. Higher scores indicate greater severity of nightmares and dream-related anxiety.

Dream content evaluation

时间窗: Through study completion, an average of 18 months

Dream Diary

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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