Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631807
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-31
Brief Title:
The Impact of the Years of Blindness on Sleep and Dreaming Processes and the Relationships With Spatial Abilities
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of the Years of Blindness on Sleep and Dreaming Processes and Possible Relationships With Spatial Abilities
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 psychologicalbehavioral 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 p005 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 andor 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 p005 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 andor Fieldtrip toolboxes will be utilized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None