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

NCT06631807 | Enrolling By Invitation

• 1 other identifier: IIT_UVIP_BLINDREAM_2022
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Blindness; Visual Impairment

Keywords

Blindness; sleep; PSG; circadian; dream; spatial abilities

Outcome Measures

Primary Outcomes (13)

• Sleep macrostructure

  Percentage of sleep stages and spectrogram

  Through study completion, an average of 18 months

• Sleep microstructure

  Analysis of sleep spindles

  Through study completion, an average of 18 months

• Sleep microstructure

  Analysis of slow waves

  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.

  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

  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".

  Through study completion, an average of 12 months

• Circadian shift

  Melatonin sample ELISA protocol

  Through study completion, an average of 18 months

• Circadian shift

  Actigraphy measures

  Through study completion, an average of 18 months

• Spatial perception ability

  Spatial and temporal bisection

  Through study completion, an average of 12 months

• Spatial memory ability

  Audiocorsi

  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.

  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.

  Through study completion, an average of 12 months

• Dream content evaluation

  Dream Diary

  Through study completion, an average of 18 months

Study Arms (2)

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.

Control

Control group is composed of adult participants (without visual deficits) age and gender matched with the BSI group.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Italiano di Tecnologia: lead

Study Sites (1)

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

Genova, 16132, Italy

Location

Related Publications (43)

• 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.

  PMID: 30083814 RESULT

• 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.

  PMID: 10450596 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.

  PMID: 24816752 RESULT

• 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.

  PMID: 18482109 RESULT

• 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.

  PMID: 29458742 RESULT

• 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.

  PMID: 31025801 RESULT

• 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.

  PMID: 24709309 RESULT

• 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.

  PMID: 23524011 RESULT

• 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.

  PMID: 20417102 RESULT

• 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.

  PMID: 34015442 RESULT

• 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.

  PMID: 23283685 RESULT

• 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.

  PMID: 26762182 RESULT

• 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.

  PMID: 29789897 RESULT

• 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.

  PMID: 6841552 RESULT

• 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.

  PMID: 11525322 RESULT

• Richardson C, Micic G, Cain N, Bartel K, Maddock B, Gradisar M. Cognitive performance in adolescents with Delayed Sleep-Wake Phase Disorder: Treatment effects and a comparison with good sleepers. J Adolesc. 2018 Jun;65:72-84. doi: 10.1016/j.adolescence.2018.03.002. Epub 2018 Mar 16.

  PMID: 29555485 RESULT

• 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.

  PMID: 33122670 RESULT

• Le Bon O. Relationships between REM and NREM in the NREM-REM sleep cycle: a review on competing concepts. Sleep Med. 2020 Jun;70:6-16. doi: 10.1016/j.sleep.2020.02.004. Epub 2020 Feb 15.

  PMID: 32179430 RESULT

• 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.

  PMID: 28621018 RESULT

• Leger D, Guilleminault C, Santos C, Paillard M. Sleep/wake cycles in the dark: sleep recorded by polysomnography in 26 totally blind subjects compared to controls. Clin Neurophysiol. 2002 Oct;113(10):1607-14. doi: 10.1016/s1388-2457(02)00221-3.

  PMID: 12350437 RESULT

• Hono T, Hiroshige Y, Miyata Y. A case report on EEG nocturnal sleep in visually impaired persons aged in their 30s and 50s. Psychiatry Clin Neurosci. 1999 Apr;53(2):145-7. doi: 10.1046/j.1440-1819.1999.00501.x.

  PMID: 10459673 RESULT

• Scrofani A, Cioni M, Filetti S, Lanaia F, Pennisi G, Bella R, Grasso A. Changes in sleep spindle activity of subject with chronic somatosensitive and sensorial deficits. Preliminary results. Ital J Neurol Sci. 1996 Dec;17(6):423-8. doi: 10.1007/BF01997717.

  PMID: 8978449 RESULT

• Kerr NH, Foulkes D, Schmidt M. The structure of laboratory dream reports in blind and sighted subjects. J Nerv Ment Dis. 1982 May;170(5):286-94. doi: 10.1097/00005053-198205000-00006. No abstract available.

  PMID: 7069416 RESULT

• Bertolo H, Paiva T, Pessoa L, Mestre T, Marques R, Santos R. Visual dream content, graphical representation and EEG alpha activity in congenitally blind subjects. Brain Res Cogn Brain Res. 2003 Feb;15(3):277-84. doi: 10.1016/s0926-6410(02)00199-4.

  PMID: 12527101 RESULT

• Sabo KT, Kirtley DD. Emotions in the dreams of the blind. Int J Rehabil Res. 1980;3(3):382-5. doi: 10.1097/00004356-198009000-00013. No abstract available.

  PMID: 7450997 RESULT

• Gori M. Multisensory Integration and Calibration in Children and Adults with and without Sensory and Motor Disabilities. Multisens Res. 2015;28(1-2):71-99. doi: 10.1163/22134808-00002478.

  PMID: 26152053 RESULT

• Gori M, Sandini G, Burr D. Development of visuo-auditory integration in space and time. Front Integr Neurosci. 2012 Sep 17;6:77. doi: 10.3389/fnint.2012.00077. eCollection 2012.

  PMID: 23060759 RESULT

• Gori M, Del Viva M, Sandini G, Burr DC. Young children do not integrate visual and haptic form information. Curr Biol. 2008 May 6;18(9):694-8. doi: 10.1016/j.cub.2008.04.036.

  PMID: 18450446 RESULT

• Gori M, Sandini G, Martinoli C, Burr D. Poor haptic orientation discrimination in nonsighted children may reflect disruption of cross-sensory calibration. Curr Biol. 2010 Feb 9;20(3):223-5. doi: 10.1016/j.cub.2009.11.069. Epub 2010 Jan 28.

  PMID: 20116249 RESULT

• Roder B, Rosler F, Spence C. Early vision impairs tactile perception in the blind. Curr Biol. 2004 Jan 20;14(2):121-4.

  PMID: 14738733 RESULT

• Zwiers MP, Van Opstal AJ, Cruysberg JR. A spatial hearing deficit in early-blind humans. J Neurosci. 2001 May 1;21(9):RC142: 1-5. doi: 10.1523/JNEUROSCI.21-09-j0002.2001.

  PMID: 11312316 RESULT

• Cappagli G, Cocchi E, Gori M. Auditory and proprioceptive spatial impairments in blind children and adults. Dev Sci. 2017 May;20(3). doi: 10.1111/desc.12374. Epub 2015 Nov 27.

  PMID: 26613827 RESULT

• Gori M, Sandini G, Martinoli C, Burr DC. Impairment of auditory spatial localization in congenitally blind human subjects. Brain. 2014 Jan;137(Pt 1):288-93. doi: 10.1093/brain/awt311. Epub 2013 Nov 21.

  PMID: 24271326 RESULT

• 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.

  PMID: 32048380 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.

  PMID: 32848573 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.

  PMID: 30240622 RESULT

• Setti W, Cuturi LF, Engel I, Picinali L, Gori M. The influence of early visual deprivation on audio-spatial working memory. Neuropsychology. 2022 Jan;36(1):55-63. doi: 10.1037/neu0000776. Epub 2021 Oct 14.

  PMID: 34647755 RESULT

• Setti W, Cuturi LF, Cocchi E, Gori M. A novel paradigm to study spatial memory skills in blind individuals through the auditory modality. Sci Rep. 2018 Sep 6;8(1):13393. doi: 10.1038/s41598-018-31588-y.

  PMID: 30190584 RESULT

• Ruggiero G, Iachini T. The role of vision in the Corsi block-tapping task: evidence from blind and sighted people. Neuropsychology. 2010 Sep;24(5):674-9. doi: 10.1037/a0019594.

  PMID: 20804256 RESULT

• Vecchi T, Tinti C, Cornoldi C. Spatial memory and integration processes in congenital blindness. Neuroreport. 2004 Dec 22;15(18):2787-90.

  PMID: 15597055 RESULT

• Aubin S, Gacon C, Jennum P, Ptito M, Kupers R. Altered sleep-wake patterns in blindness: a combined actigraphy and psychometric study. Sleep Med. 2016 Aug;24:100-108. doi: 10.1016/j.sleep.2016.07.021. Epub 2016 Aug 31.

  PMID: 27810175 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.

  PMID: 26951421 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.

  PMID: 15291233 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Salivary sample for melatonin analysis

MeSH Terms

Conditions

Blindness; Vision Disorders; Spatial Navigation

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spatial Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: October 8, 2024
• Study Start: April 4, 2024
• Primary Completion: October 4, 2025
• Study Completion: October 4, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)