Clinical trial NCT05050292: Cognitive Stimulation and Sleep Quality. An Innovative Intervention for Insomnia
Official title: Cognitive Stimulation Intervention Program for Insomniacs and Its Benefit on Sleep Quality, Executive Functions and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Insomnia Type; Sleep Disorder
Keywords: Insomnia
Cognitive stimulation
Cognitive intervention
Sleep disorder
Sleep quality
Lead sponsor: Universidad Antonio de Nebrija
Sponsor class: OTHER
Collaborators: name: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
First posted: 2021-09-20
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Phase I/II was designed to determine the safety of the training, the maximum tolerated training time per session, and the needed training sessions to obtain significant cognitive performance improvement prior to beginning with the cognitive stimulation intervention program (Phase III).

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.

Eligibility criteria: Inclusion Criteria:

* 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:

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:

* 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.

Primary outcomes:
measure: Change from Baseline in Sleep quality on the Pittsburgh Sleep Quality Index at Week 8
timeFrame: 1 day before starting the intervention and 1 day after finishing the intervention
measure: Change from Baseline in Insomnia on the Insomnia Severity Index at Week 8
timeFrame: 1 day before starting the intervention and 1 day after finishing the intervention
measure: Change from Baseline in Quality of life on Measuring Quality of Life | The World Health Organization - abridged version
timeFrame: 1 day before starting the intervention and 1 day after finishing the intervention
Secondary outcomes:
measure: Change from Baseline in Executive function on Behavior Rating Inventory of Executive Function-Adult Version at Week 8
timeFrame: 1 day before starting the intervention and 1 day after finishing the intervention
measure: Change from Baseline in Depressive symptoms on The Beck Depression Inventory-II at Week 8
timeFrame: 1 day before starting the intervention and 1 day after finishing the intervention
measure: Change from Baseline in Anxiety symptoms on the State-Trait Anxiety Inventory at Week 8
timeFrame: 1 day before starting the intervention and 1 day after finishing the intervention
measure: Change from Baseline in worrying on The Penn State Worry Questionnaire at Week 8
timeFrame: 1 day before starting the intervention and 1 day after finishing the intervention
Other outcomes:
Locations:
city: Alzira
country: Spain
facility: Hospital Universitario de la Ribera
state: Valencia
Study officials:
affiliation: Universidad Nebrija
name: Jon A Duñabeitia
role: STUDY_DIRECTOR
affiliation: Univerisdad Nebrija
name: Jose L Tapia
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bastien CH, Vallieres A, Morin CM. Precipitating factors of insomnia. Behav Sleep Med. 2004;2(1):50-62. doi: 10.1207/s15402010bsm0201_5.
citation: 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.
citation: 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.
citation: 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.
citation: Harvey AG. A cognitive model of insomnia. Behav Res Ther. 2002 Aug;40(8):869-93. doi: 10.1016/s0005-7967(01)00061-4.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.