Cognitive Stimulation and Sleep Quality. An Innovative Intervention for Insomnia

NCT05050292 | Unknown

• 1 other identifier: CIBEF21
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are a) to investigate the effect of a personalized and computerized cognitive stimulation program on sleep quality, cognitive performance, and quality of life; and b) verify if cognitive stimulation can be used as a non-pharmacological alternative to improve the quality of sleep in individuals who have insomnia.

Conditions

Insomnia; Insomnia Type; Sleep Disorder

Keywords

Insomnia; Cognitive stimulation; Cognitive intervention; Sleep disorder; Sleep quality

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Sleep quality on the Pittsburgh Sleep Quality Index at Week 8

  The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. Change = (Week 8 Score - Baseline Score).

  1 day before starting the intervention and 1 day after finishing the intervention

• Change from Baseline in Insomnia on the Insomnia Severity Index at Week 8

  The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It comprises seven items assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Possible scores ranges from 0 (No clinically significant insomnia) to 28 (Clinically insomnia - Severe). Change = (Week 8 Score - Baseline Score).

  1 day before starting the intervention and 1 day after finishing the intervention

• Change from Baseline in Quality of life on Measuring Quality of Life | The World Health Organization - abridged version

  The Measuring Quality of Life \| The World Health Organization - abridged version (WHOQOL-BREF) is a generic questionnaire to measure the quality of life created by the Study Group on Quality of Life of the World Health Organization. It has 26 questions, two general questions on the quality of life and satisfaction with the state health, and 24 questions grouped into four areas or domains: Physical Health, Psychological Health, Social Relations and Environment. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval. Possible scores for each domain ranges from 0 (poor perceived quality of life) to 100 (greater perceived quality of life). Change = (Week 8 Score - Baseline Score).

  1 day before starting the intervention and 1 day after finishing the intervention

Secondary Outcomes (4)

• Change from Baseline in Executive function on Behavior Rating Inventory of Executive Function-Adult Version at Week 8

  1 day before starting the intervention and 1 day after finishing the intervention

• Change from Baseline in Depressive symptoms on The Beck Depression Inventory-II at Week 8

  1 day before starting the intervention and 1 day after finishing the intervention

• Change from Baseline in Anxiety symptoms on the State-Trait Anxiety Inventory at Week 8

  1 day before starting the intervention and 1 day after finishing the intervention

• Change from Baseline in worrying on The Penn State Worry Questionnaire at Week 8

  1 day before starting the intervention and 1 day after finishing the intervention

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: Personalized cognitive stimulation

Control Group

ACTIVE COMPARATOR

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.

Other: Sham cognitive stimulation

Interventions

Personalized cognitive stimulation OTHER

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.

Also known as: CogniFit's personalized brain training

Experimental Group

Sham cognitive stimulation OTHER

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.

Control Group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be diagnosed by Insomnia Disorder \[307.42 (F51.01)\]:
• A. A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
• Difficulty initiating sleep. (In children, this may manifest as difficulty initiating sleep without caregiver intervention.)
• 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.)
• 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.

You may not qualify if:

• Have another sleep-wake disorder (e.g., narcolepsy, restless leg syndrome, a breathing-related sleep disorder, a circadian sleep-wake rhythm disorder, a parasomnia).
• 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.

Sponsors & Collaborators

• Universidad Antonio de Nebrija: lead
• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: collaborator

Study Sites (1)

Hospital Universitario de la Ribera

Alzira, Valencia, 46600, Spain

Location

Related Publications (16)

• 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.

  PMID: 18548835 BACKGROUND

• Bastien CH, Vallieres A, Morin CM. Precipitating factors of insomnia. Behav Sleep Med. 2004;2(1):50-62. doi: 10.1207/s15402010bsm0201_5.

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• 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.

  PMID: 22467988 BACKGROUND

• 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.

  PMID: 11752485 BACKGROUND

• 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.

  PMID: 23577218 BACKGROUND

• Harvey AG. A cognitive model of insomnia. Behav Res Ther. 2002 Aug;40(8):869-93. doi: 10.1016/s0005-7967(01)00061-4.

  PMID: 12186352 BACKGROUND

• 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.

  PMID: 21967449 BACKGROUND

• 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.

  PMID: 28453603 BACKGROUND

• 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.

  PMID: 25364074 BACKGROUND

• 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.

  PMID: 32005351 BACKGROUND

• 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.

  PMID: 29448003 BACKGROUND

• 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.

  PMID: 9358396 BACKGROUND

• 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.

  PMID: 25895933 BACKGROUND

• 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.

  PMID: 11123521 BACKGROUND

• 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.

  PMID: 36992590 DERIVED

• 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.

  PMID: 35296055 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jon A Duñabeitia

  Universidad Nebrija

  STUDY DIRECTOR

• Jose L Tapia

  Univerisdad Nebrija

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be randomly assigned to one out of two groups (control/experimental). 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: The intervention will be carried out through the CogniFit® online platform so participants will access it from home using a personal computer or smart device. The training will last for a total of 8 weeks (40 training sessions), with five consecutive training days per week (Monday to Friday). Since this process is autonomous, participants will be contacted periodically (a minimum of one phone call per week) to ensure adherence and check that they have not had any incidence. The platform will records participants' performance, providing researchers with real-time feedback on the performance of each participant.

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 20, 2021
• Study Start: October 4, 2021
• Primary Completion: March 16, 2023
• Study Completion: March 16, 2023
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)