The Impact of the Years of Blindness on Sleep and Dreaming Processes and the Relationships With Spatial Abilities
NCT ID: NCT06631807
Last Updated: 2024-10-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ENROLLING_BY_INVITATION
Total Enrollment
40 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-04-04
Study Completion Date
2025-10-04
Brief Summary
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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.
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Detailed Description
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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.
Each phase involves different sessions: the circadian assessment requires wearing an actigraphic bracelet for a week, during which salivary melatonin will also be measured; the sleep and dream assessment involves wearing a home polysomnograph for one night and completing a verbal dream diary for one week; and the neuropsychological assessment will be conducted in a single session lasting between approximately 30 minutes and 2 hours.
The study will include adult individuals both with and without visual impairments. The visual impairment may be congenital or acquired later in life. Control group participants will be selected to match the experimental group (those with visual impairments) in terms of age and gender. Due to the proof-of-concept nature of the study and the lack of prior estimates of effect sizes, power calculations are not currently possible. The sample size is therefore based on a provisional and conservative estimate of recruitment capacity, informed by previous literature. However, efforts will be made to conduct interim analyses to estimate effect sizes based on the primary outcome and adjust assumptions accordingly. The study currently aims to recruit 20 blind participants and 20 healthy controls.
Therefore, the preliminary data will utilize the Power Analysis method to calculate the minimum sample size required to achieve a correct effect size for a given dimension. The data will be analyzed using both parametric and non-parametric tests, and differences between groups will be assessed with t-tests, ANOVA, TANCOVA, and linear mixed models where appropriate. An appropriate post-hoc test will be conducted if significance is found. The significance level will be considered at p\<0.05. Where necessary, parametric techniques will be replaced by non-parametric equivalents. The standard software used will include: Matlab, R, Origin, Statistica, and SPSS, recognized in the research field. For the analysis of electroencephalographic data, EEGlab and/or Fieldtrip toolboxes will be utilized.
* 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.
Each phase involves different sessions: the circadian assessment requires wearing an actigraphic bracelet for a week, during which salivary melatonin will also be measured; the sleep and dream assessment involves wearing a home polysomnograph for one night and completing a verbal dream diary for one week; and the neuropsychological assessment will be conducted in a single session lasting between approximately 30 minutes and 2 hours.
The study will include adult individuals both with and without visual impairments. The visual impairment may be congenital or acquired later in life. Control group participants will be selected to match the experimental group (those with visual impairments) in terms of age and gender. Due to the proof-of-concept nature of the study and the lack of prior estimates of effect sizes, power calculations are not currently possible. The sample size is therefore based on a provisional and conservative estimate of recruitment capacity, informed by previous literature. However, efforts will be made to conduct interim analyses to estimate effect sizes based on the primary outcome and adjust assumptions accordingly. The study currently aims to recruit 20 blind participants and 20 healthy controls.
Therefore, the preliminary data will utilize the Power Analysis method to calculate the minimum sample size required to achieve a correct effect size for a given dimension. The data will be analyzed using both parametric and non-parametric tests, and differences between groups will be assessed with t-tests, ANOVA, TANCOVA, and linear mixed models where appropriate. An appropriate post-hoc test will be conducted if significance is found. The significance level will be considered at p\<0.05. Where necessary, parametric techniques will be replaced by non-parametric equivalents. The standard software used will include: Matlab, R, Origin, Statistica, and SPSS, recognized in the research field. For the analysis of electroencephalographic data, EEGlab and/or Fieldtrip toolboxes will be utilized.
Conditions
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Blindness
Visual Impairment
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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Blind and severely visually impaired (BSI)
This group is composed of adults participants (ages of ≥ 18 and ≤ 85 years) with an impairment of the peripheral visual system (i.e., involving pre-chiasmatic structures, such as the retina and optic nerve). The visual deficit can be congenital (from birth) or have a late onset. Participants with visual impairment, classified according to the current diagnostic criteria, must have residual vision lower than 1.0 LogMAR. Participant of any gender and ethnicity are considered, provided they have a good knowledge of the Italian language.
No interventions assigned to this group
Control
Control group is composed of adult participants (without visual deficits) age and gender matched with the BSI group.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Istituto Italiano di Tecnologia
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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U.O. Clinica Neurologica Ambul. disturbi del sonno ed epilessia; IRCCS Ospedale Policlinico San Martino
Genova, , Italy
Site Status
Countries
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Italy
References
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Hartley S, Dauvilliers Y, Quera-Salva MA. Circadian Rhythm Disturbances in the Blind. Curr Neurol Neurosci Rep. 2018 Aug 6;18(10):65. doi: 10.1007/s11910-018-0876-9.
Reference Type
RESULT
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RESULT
Depner CM, Stothard ER, Wright KP Jr. Metabolic consequences of sleep and circadian disorders. Curr Diab Rep. 2014 Jul;14(7):507. doi: 10.1007/s11892-014-0507-z.
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RESULT
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Meaidi A, Jennum P, Ptito M, Kupers R. The sensory construction of dreams and nightmare frequency in congenitally blind and late blind individuals. Sleep Med. 2014 May;15(5):586-95. doi: 10.1016/j.sleep.2013.12.008. Epub 2014 Feb 18.
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Wamsley EJ, Tucker M, Payne JD, Benavides JA, Stickgold R. Dreaming of a learning task is associated with enhanced sleep-dependent memory consolidation. Curr Biol. 2010 May 11;20(9):850-5. doi: 10.1016/j.cub.2010.03.027. Epub 2010 Apr 22.
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Picard-Deland C, Aumont T, Samson-Richer A, Paquette T, Nielsen T. Whole-body procedural learning benefits from targeted memory reactivation in REM sleep and task-related dreaming. Neurobiol Learn Mem. 2021 Sep;183:107460. doi: 10.1016/j.nlm.2021.107460. Epub 2021 May 18.
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Chellappa SL, Morris CJ, Scheer FAJL. Circadian misalignment increases mood vulnerability in simulated shift work. Sci Rep. 2020 Oct 29;10(1):18614. doi: 10.1038/s41598-020-75245-9.
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Aubin S, Jennum P, Nielsen T, Kupers R, Ptito M. Sleep structure in blindness is influenced by circadian desynchrony. J Sleep Res. 2018 Feb;27(1):120-128. doi: 10.1111/jsr.12548. Epub 2017 Jun 16.
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Gori M, Amadeo MB, Campus C. Temporal cues trick the visual and auditory cortices mimicking spatial cues in blind individuals. Hum Brain Mapp. 2020 Jun 1;41(8):2077-2091. doi: 10.1002/hbm.24931. Epub 2020 Feb 12.
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RESULT
Amadeo MB, Campus C, Gori M. Years of Blindness Lead to "Visualize" Space Through Time. Front Neurosci. 2020 Aug 4;14:812. doi: 10.3389/fnins.2020.00812. eCollection 2020.
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RESULT
Gori M, Amadeo MB, Campus C. Temporal Cues Influence Space Estimations in Visually Impaired Individuals. iScience. 2018 Aug 31;6:319-326. doi: 10.1016/j.isci.2018.07.003. Epub 2018 Aug 1.
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RESULT
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RESULT
Flynn-Evans EE, Lockley SW. A Pre-Screening Questionnaire to Predict Non-24-Hour Sleep-Wake Rhythm Disorder (N24HSWD) among the Blind. J Clin Sleep Med. 2016 May 15;12(5):703-10. doi: 10.5664/jcsm.5800.
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RESULT
Schredl M. Reliability and stability of a dream recall frequency scale. Percept Mot Skills. 2004 Jun;98(3 Pt 2):1422-6. doi: 10.2466/pms.98.3c.1422-1426.
Reference Type
RESULT
Other Identifiers
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IIT_UVIP_BLINDREAM_2022
Identifier Type: -
Identifier Source: org_study_id
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