Cognitive Stimulation and Sleep Quality. An Innovative Intervention for Insomnia
NCT ID: NCT05050292
Last Updated: 2022-11-03
Study Results
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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2021-10-04
2023-03-16
Brief Summary
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Detailed Description
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Phase I/II
Through a 3+3 design, a dose-escalation trial will be set. Participants will be tested across subsequent training blocks of 15 minutes each, reporting experienced fatigue or adverse effects after every block. The safe training dose will be set to a block before extreme fatigue or a notable adverse effect has been reported by two or more participants.
Once a safety training time has been established, 20 participants will engage in a 15-day training effectiveness assessment. An evaluation day and a training day will be interspersed so that participants will complete a total of 7 training sessions (days 2, 4, 6, 8, 10, 12, and 14) and 8 evaluation sessions (days 1, 3, 5, 7, 9, 11, 13, and 15).
A psychologist will be supervising every step of the process at all times.
Phase III
A total of 120 persons with insomnia will undergo an 8-week cognitive stimulation program, five consecutive days per week. Eligible participants will be randomized in a 1:1 ratio to an intervention or control group. Activities duration per day will be as set on phase I.
This final phase is set to be an online home-based stage, although the responsible psychologist will periodically contact participants via telephone.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
The activities presented to Group 1 (experimental group) will target executive functions skills and will be automatically adjusted in difficulty and requirement according to each participant's performance so that a maximum cognitive effort is always required.
The activities for Group 2 (active control group) will be of constant difficulty throughout the intervention and will not target the intended cognitive processes (namely, they will target orthogonal unrelated aspects).
Participants and researchers are blind to whether they are in the intervention or the control group. In this way, placebo or waiting-list effects are avoided.
Study Groups
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Experimental Group
Activities are designed to target specific cognitive skills (attention, perception, inhibition).
An internal algorithm of the cognitive stimulation platform will adjust the activities' difficulty depending on the participant's performance, always demanding a maximum cognitive effort.
Personalized cognitive stimulation
Online gamified activities designed to stimulate cognitive functions (specifically executive function) will be carried out through a mobile application or web browser.
Performance feedback will be shown after each activity.
Control Group
Painting and artistic activities not designed to target specific cognitive skills.
The internal algorithm will be deactivated, so the cognitive stimulation activities will be of constant difficulty throughout the intervention.
Sham cognitive stimulation
Non-therapeutic online games based on artistic and creative tasks. Activities will match in duration to those of the experimental intervention.
Performance feedback will be shown after each game.
Interventions
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Personalized cognitive stimulation
Online gamified activities designed to stimulate cognitive functions (specifically executive function) will be carried out through a mobile application or web browser.
Performance feedback will be shown after each activity.
Sham cognitive stimulation
Non-therapeutic online games based on artistic and creative tasks. Activities will match in duration to those of the experimental intervention.
Performance feedback will be shown after each game.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
A. A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
1. Difficulty initiating sleep. (In children, this may manifest as difficulty initiating sleep without caregiver intervention.)
2. Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. (In children, this may manifest as difficulty returning to sleep without caregiver intervention.)
3. Early-morning awakening with inability to return to sleep.
B. The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.
C. The sleep difficulty occurs at least 3 nights per week.
D. The sleep difficulty is present for at least 3 months.
E. The sleep difficulty occurs despite adequate opportunity for sleep.
F. The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder (e.g., narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia).
G. The insomnia is not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication).
H. Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.
Exclusion Criteria
* Presence of a relevant medical, psychiatric or neurological disorder.
* Significant visual or motor impairments.
* History of alcohol or drug abuse or dependence.
* Caffeine consumption (more than 150mg per day, that is, approximately 3 cups of espresso or a cup of American coffee).
* Alcohol consumption (more than 250ml per day, that is, around a pint of beer, a glass of wine, or a shot of liquor).
* Use of medications with stimulant action, except sedatives or hypnotics prescribed for sleep.
25 Years
55 Years
ALL
No
Sponsors
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Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
OTHER
Universidad Antonio de Nebrija
OTHER
Responsible Party
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Jon Andoni Duñabeitia
Director
Principal Investigators
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Jon A Duñabeitia
Role: STUDY_DIRECTOR
Universidad Nebrija
Jose L Tapia
Role: PRINCIPAL_INVESTIGATOR
Univerisdad Nebrija
Locations
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Hospital Universitario de la Ribera
Alzira, Valencia, Spain
Countries
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References
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Bastien CH, St-Jean G, Morin CM, Turcotte I, Carrier J. Chronic psychophysiological insomnia: hyperarousal and/or inhibition deficits? An ERPs investigation. Sleep. 2008 Jun;31(6):887-98. doi: 10.1093/sleep/31.6.887.
Bastien CH, Vallieres A, Morin CM. Precipitating factors of insomnia. Behav Sleep Med. 2004;2(1):50-62. doi: 10.1207/s15402010bsm0201_5.
Corsi-Cabrera M, Figueredo-Rodriguez P, del Rio-Portilla Y, Sanchez-Romero J, Galan L, Bosch-Bayard J. Enhanced frontoparietal synchronized activation during the wake-sleep transition in patients with primary insomnia. Sleep. 2012 Apr 1;35(4):501-11. doi: 10.5665/sleep.1734.
Espie CA. Insomnia: conceptual issues in the development, persistence, and treatment of sleep disorder in adults. Annu Rev Psychol. 2002;53:215-43. doi: 10.1146/annurev.psych.53.100901.135243.
Haimov I, Shatil E. Cognitive training improves sleep quality and cognitive function among older adults with insomnia. PLoS One. 2013;8(4):e61390. doi: 10.1371/journal.pone.0061390. Epub 2013 Apr 5.
Harvey AG. A cognitive model of insomnia. Behav Res Ther. 2002 Aug;40(8):869-93. doi: 10.1016/s0005-7967(01)00061-4.
Harvey AG, Tang NK. (Mis)perception of sleep in insomnia: a puzzle and a resolution. Psychol Bull. 2012 Jan;138(1):77-101. doi: 10.1037/a0025730. Epub 2011 Oct 3.
Aasvik J, Stiles TC, Woodhouse A, Borchgrevink P, Inge Landro N. The Effect of Insomnia on Neuropsychological Functioning in Patients with Comorbid Symptoms of Pain, Fatigue, and Mood Disorders. Arch Clin Neuropsychol. 2018 Feb 1;33(1):14-23. doi: 10.1093/arclin/acx040.
Fortier-Brochu E, Morin CM. Cognitive impairment in individuals with insomnia: clinical significance and correlates. Sleep. 2014 Nov 1;37(11):1787-98. doi: 10.5665/sleep.4172.
Brownlow JA, Miller KE, Gehrman PR. Insomnia and Cognitive Performance. Sleep Med Clin. 2020 Mar;15(1):71-76. doi: 10.1016/j.jsmc.2019.10.002. Epub 2019 Nov 27.
Leerssen J, Wassing R, Ramautar JR, Stoffers D, Lakbila-Kamal O, Perrier J, Bruijel J, Foster-Dingley JC, Aghajani M, van Someren EJW. Increased hippocampal-prefrontal functional connectivity in insomnia. Neurobiol Learn Mem. 2019 Apr;160:144-150. doi: 10.1016/j.nlm.2018.02.006. Epub 2018 Feb 12.
Perlis ML, Giles DE, Mendelson WB, Bootzin RR, Wyatt JK. Psychophysiological insomnia: the behavioural model and a neurocognitive perspective. J Sleep Res. 1997 Sep;6(3):179-88. doi: 10.1046/j.1365-2869.1997.00045.x.
Riemann D, Nissen C, Palagini L, Otte A, Perlis ML, Spiegelhalder K. The neurobiology, investigation, and treatment of chronic insomnia. Lancet Neurol. 2015 May;14(5):547-58. doi: 10.1016/S1474-4422(15)00021-6. Epub 2015 Apr 12.
Thomas M, Sing H, Belenky G, Holcomb H, Mayberg H, Dannals R, Wagner H, Thorne D, Popp K, Rowland L, Welsh A, Balwinski S, Redmond D. Neural basis of alertness and cognitive performance impairments during sleepiness. I. Effects of 24 h of sleep deprivation on waking human regional brain activity. J Sleep Res. 2000 Dec;9(4):335-52. doi: 10.1046/j.1365-2869.2000.00225.x.
Tapia JL, Puertas FJ, Dunabeitia JA. Digital Therapeutics for Insomnia: Assessing the Effectiveness of a Computerized Home-Based Cognitive Stimulation Program. J Integr Neurosci. 2023 Feb 14;22(2):34. doi: 10.31083/j.jin2202034.
Tapia JL, Puertas FJ, Dunabeitia JA. Study Protocol for a Randomized Controlled Trial Assessing the Effectiveness of Personalized Computerized Cognitive Training for Individuals With Insomnia. Front Behav Neurosci. 2022 Feb 28;16:779990. doi: 10.3389/fnbeh.2022.779990. eCollection 2022.
Other Identifiers
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CIBEF21
Identifier Type: -
Identifier Source: org_study_id
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