An observational study in Blindness and Visual Impairment, sponsored by Istituto Italiano di Tecnologia. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Istituto Italiano di Tecnologia · Observational
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.
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:
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:
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.
144 studies on the registry are indexed under Blindness; 33 are open to participants now.
This study's planned enrollment of 40 is below the median of 76 across 35 observational studies indexed under Blindness.
Browse Blindness studies →Istituto Italiano di Tecnologia is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Control group is composed of adult participants (without visual deficits) age and gender matched with the BSI group.
Sleep macrostructure
Percentage of sleep stages and spectrogram
Time frame: Through study completion, an average of 18 months
Sleep microstructure
Analysis of sleep spindles
Time frame: Through study completion, an average of 18 months
Sleep microstructure
Analysis of slow waves
Time frame: Through study completion, an average of 18 months
Sleep quality - PSQI
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.
Time frame: Through study completion, an average of 12 months
Sleep Quality - questionnaire to predict N24HSWD
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
Time frame: Through study completion, an average of 12 months
Sleep quality - MEQ
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".
Time frame: Through study completion, an average of 12 months
Circadian shift
Melatonin sample ELISA protocol
Time frame: Through study completion, an average of 18 months
Circadian shift
Actigraphy measures
Time frame: Through study completion, an average of 18 months
Spatial perception ability
Spatial and temporal bisection
Time frame: Through study completion, an average of 12 months
Spatial memory ability
Audiocorsi
Time frame: Through study completion, an average of 12 months
Dream content evaluation - DRFS
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.
Time frame: Through study completion, an average of 12 months
Dream content evaluation - VDAS
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.
Time frame: Through study completion, an average of 12 months
Dream content evaluation
Dream Diary
Time frame: Through study completion, an average of 18 months
Plan to share: Yes — IPD that underlie results in a publication
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Istituto Italiano di Tecnologia