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BlindnessNCT06631807

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

An observational study of Blindness and Visual Impairment, run by Istituto Italiano di Tecnologia at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Blindness, Visual Impairment
How many people
40 participants
Where
1 siteItaly
Study dates
4 Apr 2024to 4 Oct 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • U.O. Clinica Neurologica Ambul. disturbi del sonno ed epilessia; IRCCS Ospedale Policlinico San Martino

    Genova, 16132

Other trials in Italy

About this study

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

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.

Read the 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, 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.

Keywords
Blindness, sleep, PSG, circadian, dream, spatial abilities
Medical subject headings
Blindness, Vision Disorders, Spatial Navigation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06631807
Study groupRoleWhat they receive
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.
ControlControl group is composed of adult participants (without visual deficits) age and gender matched with the BSI group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep macrostructure

    Percentage of sleep stages and spectrogram

    Measured: Through study completion, an average of 18 months

  2. Sleep microstructure

    Analysis of sleep spindles

    Measured: Through study completion, an average of 18 months

  3. Sleep microstructure

    Analysis of slow waves

    Measured: Through study completion, an average of 18 months

  4. 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.

    Measured: Through study completion, an average of 12 months

  5. 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

    Measured: Through study completion, an average of 12 months

  6. 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".

    Measured: Through study completion, an average of 12 months

  7. Circadian shift

    Melatonin sample ELISA protocol

    Measured: Through study completion, an average of 18 months

  8. Circadian shift

    Actigraphy measures

    Measured: Through study completion, an average of 18 months

  9. Spatial perception ability

    Spatial and temporal bisection

    Measured: Through study completion, an average of 12 months

  10. Spatial memory ability

    Audiocorsi

    Measured: Through study completion, an average of 12 months

  11. 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.

    Measured: Through study completion, an average of 12 months

  12. 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.

    Measured: Through study completion, an average of 12 months

  13. Dream content evaluation

    Dream Diary

    Measured: Through study completion, an average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start4 Apr 2024
  3. Primary completion4 Oct 2025 (estimated)
  4. Study completion4 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06631807
Sponsor's protocol ID
IIT_UVIP_BLINDREAM_2022
Status last verified
Oct 2024
First submitted
31 Aug 2024
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD that underlie results in a publication

Publications

  • 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.

    PubMed 30083814

  • Lockley SW, Skene DJ, Butler LJ, Arendt J. Sleep and activity rhythms are related to circadian phase in the blind. Sleep. 1999 Aug 1;22(5):616-23. doi: 10.1093/sleep/22.5.616.

    PubMed 10450596

  • 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.

    PubMed 24816752

  • Lockley SW, Dijk DJ, Kosti O, Skene DJ, Arendt J. Alertness, mood and performance rhythm disturbances associated with circadian sleep disorders in the blind. J Sleep Res. 2008 Jun;17(2):207-16. doi: 10.1111/j.1365-2869.2008.00656.x.

    PubMed 18482109

  • Aubin S, Christensen JAE, Jennum P, Nielsen T, Kupers R, Ptito M. Preserved sleep microstructure in blind individuals. Sleep Med. 2018 Feb;42:21-30. doi: 10.1016/j.sleep.2017.11.1135. Epub 2017 Dec 7.

    PubMed 29458742

  • Christensen JAE, Aubin S, Nielsen T, Ptito M, Kupers R, Jennum P. Rapid eye movements are reduced in blind individuals. J Sleep Res. 2019 Dec;28(6):e12866. doi: 10.1111/jsr.12866. Epub 2019 Apr 26.

    PubMed 31025801

  • 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.

    PubMed 24709309

  • Chellappa SL, Cajochen C. Ultradian and circadian modulation of dream recall: EEG correlates and age effects. Int J Psychophysiol. 2013 Aug;89(2):165-70. doi: 10.1016/j.ijpsycho.2013.03.006. Epub 2013 Mar 20.

    PubMed 23524011

  • 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.

    PubMed 20417102

  • 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.

    PubMed 34015442

  • Eichenlaub JB, Bertrand O, Morlet D, Ruby P. Brain reactivity differentiates subjects with high and low dream recall frequencies during both sleep and wakefulness. Cereb Cortex. 2014 May;24(5):1206-15. doi: 10.1093/cercor/bhs388. Epub 2013 Jan 2.

    PubMed 23283685

  • Borbely AA, Daan S, Wirz-Justice A, Deboer T. The two-process model of sleep regulation: a reappraisal. J Sleep Res. 2016 Apr;25(2):131-43. doi: 10.1111/jsr.12371. Epub 2016 Jan 14.

    PubMed 26762182

  • Dirks C, Grunewald D, Young P, Heidbreder A. [Pilot study to investigate sleep disorders in the blind and persons with relevant visual impairment]. Ophthalmologe. 2019 May;116(5):435-440. doi: 10.1007/s00347-018-0723-z. German.

    PubMed 29789897

  • Lewy AJ, Newsome DA. Different types of melatonin circadian secretory rhythms in some blind subjects. J Clin Endocrinol Metab. 1983 Jun;56(6):1103-7. doi: 10.1210/jcem-56-6-1103.

    PubMed 6841552

  • De Volder AG, Toyama H, Kimura Y, Kiyosawa M, Nakano H, Vanlierde A, Wanet-Defalque MC, Mishina M, Oda K, Ishiwata K, Senda M. Auditory triggered mental imagery of shape involves visual association areas in early blind humans. Neuroimage. 2001 Jul;14(1 Pt 1):129-39. doi: 10.1006/nimg.2001.0782.

    PubMed 11525322

Questions about this trial

What is this clinical trial studying?

An observational study of Blindness and Visual Impairment, run by Istituto Italiano di Tecnologia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep macrostructure (time frame: Through study completion, an average of 18 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06631807, which also lists 43 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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