InsomniaNCT05050292

Cognitive Stimulation and Sleep Quality. An Innovative Intervention for Insomnia

A study testing Personalized cognitive stimulation in people with Insomnia and Insomnia Type; Sleep Disorder, run by Universidad Antonio de Nebrija at 1 site in Spain.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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… Read more about this study

Who is it for?: Ages 25 to 55 years
Conditions the study is for: Insomnia, Insomnia Type; Sleep Disorder
What is being tested?: Personalized cognitive stimulation
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteSpain
Study dates: 4 Oct 2021to 16 Mar 2023
Phase: Interventional
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 25 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Be diagnosed by Insomnia Disorder [307.42 (F51.01)]:
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.
The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.

Show all 12Show fewer

The sleep difficulty occurs at least 3 nights per week.
The sleep difficulty is present for at least 3 months.
The sleep difficulty occurs despite adequate opportunity for sleep.
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).
The insomnia is not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication).
Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitario de la Ribera
Alzira, Valencia, 46600

Other trials in Spain

About this study

Official title: Cognitive Stimulation Intervention Program for Insomniacs and Its Benefit on Sleep Quality, Executive Functions and Quality of Life

Read the 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.

Conditions: Insomnia, Insomnia Type; Sleep Disorder
Being tested: Personalized cognitive stimulation, Sham cognitive stimulation
Keywords: Insomnia, Cognitive stimulation, Cognitive intervention, Sleep disorder, Sleep quality
Medical subject headings: Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders

What participants receive

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

Personalized cognitive stimulationOther
Also called CogniFit's personalized brain training
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 stimulationOther
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.

Study groups in NCT05050292
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Sham cognitive stimulation

What is being measured

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

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).
Measured: 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).
Measured: 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).
Measured: 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
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a standardised measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Only the self-report format will be used. The BRIEF-A is composed of 75 items within nine theoretically and empirically derived clinical scales that measure various aspects of executive functioning; Inhibit, Self-Monitor, Plan/Organise, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, Organisation of Materials. The clinical scales form two broader indexes: Behavioral Regulation (BRI) and Metacognition (MI), and these indexes form the overall summary score, the Global Executive Composite (GEC). Also includes three validity scales (Negativity, Inconsistency, and Infrequency). It takes approximately 10-15 minutes to administer. All 75 items are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). Raw scores for each scale are summed
Measured: 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
The Beck Depression Inventory-II (BDI-II) is a 21-item, self-report inventory designed to measure the frequency and severity of depressive symptoms. Items include somatic-affective symptoms as well as cognitive symptoms. Possible scores ranges from 0 (no depressive symptoms) to 63 (severe depression). Change = (Week 8 Score - Baseline Score).
Measured: 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
The State-Trait Anxiety Inventory (STAI) is a self-report that assesses two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Only the 20 items referred to state anxiety will be administered. Possible scores ranges from 0 (no anxiety) to 60 (severe anxiety). Change = (Week 8 Score - Baseline Score).
Measured: 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
The Penn State Worry Questionnaire (PSWQ) is a 16-item questionnaire that aims to measure the trait of worry. The items on the scale assess the occurrence, intrusiveness, pervasiveness, and other characterizing features of an individual's experience with worry. The scale has been shown to identify worry, over and above anxiety and depression. Items are rated on a five-point scale: 1-Not at all typical of me to 5-Very typical of me. Possible scores ranges from 16 (low worry) to 80 (high worry). Change = (Week 8 Score - Baseline Score).
Measured: 1 day before starting the intervention and 1 day after finishing the intervention

Timeline

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

4 Oct 202116 Mar 2023

First posted20 Sep 2021
Study start4 Oct 2021
Primary completion16 Mar 2023 (estimated)
Study completion16 Mar 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for InsomniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
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.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05050292
Sponsor's protocol ID: CIBEF21
Status last verified: Nov 2022
First submitted: 6 Sep 2021
Last updated: 3 Nov 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to the institutional restrictions that regulate the data protection of patients in the Spanish public health system, it is not possible for the investigators to share any individual participant data.

Publications

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.
PubMed 18548835
Bastien CH, Vallieres A, Morin CM. Precipitating factors of insomnia. Behav Sleep Med. 2004;2(1):50-62. doi: 10.1207/s15402010bsm0201_5.
PubMed 15600224
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.
PubMed 22467988
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.
PubMed 11752485
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.
PubMed 23577218
Harvey AG. A cognitive model of insomnia. Behav Res Ther. 2002 Aug;40(8):869-93. doi: 10.1016/s0005-7967(01)00061-4.
PubMed 12186352
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.
PubMed 21967449
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.
PubMed 28453603
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.
PubMed 25364074
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.
PubMed 32005351
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.
PubMed 29448003
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.
PubMed 9358396
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.
PubMed 25895933
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.
PubMed 11123521
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.
PubMed 36992590

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive Stimulation Intervention Program for Insomniacs and Its Benefit on Sleep Quality, Executive Functions and Quality of Life
ClinicalTrials.gov ID: NCT05050292
Acronym / sponsor ID: CIBEF21
Conditions: Insomnia, Insomnia Type; Sleep Disorder
Keywords: Insomnia, Cognitive stimulation, Cognitive intervention, Sleep disorder, Sleep quality
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: Universidad Antonio de NebrijaUniversity, hospital or other
Collaborators: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study start: 4 Oct 2021 (actual)
Primary completion: 16 Mar 2023 (estimated)
Study completion: 16 Mar 2023 (estimated)
First posted: 20 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Phase I/II

A psychologist will be supervising every step of the process at all times.

Phase III

This final phase is set to be an online home-based stage, although the responsible psychologist will periodically contact participants via telephone.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 2
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.

Arm	Type	Receives
Experimental Group	Experimental	Other: Personalized cognitive stimulationActivities 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.
Control Group	Active comparator	Other: Sham cognitive stimulationPainting 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.

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Be diagnosed by Insomnia Disorder [307.42 (F51.01)]:
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.

Key exclusion criteria (7 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Personalized cognitive stimulationAlso: CogniFit's personalized brain trainingOnline 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.	Other	Experimental Group
Sham cognitive stimulationNon-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	Control Group

Primary outcome

Change from Baseline in Sleep quality on the Pittsburgh Sleep Quality Index at Week 8
Time frame: 1 day before starting the intervention and 1 day after finishing the intervention
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).
Change from Baseline in Insomnia on the Insomnia Severity Index at Week 8
Time frame: 1 day before starting the intervention and 1 day after finishing the intervention
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).
Change from Baseline in Quality of life on Measuring Quality of Life | The World Health Organization - abridged version
Time frame: 1 day before starting the intervention and 1 day after finishing the intervention
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).

4 secondary outcomes

Change from Baseline in Executive function on Behavior Rating Inventory of Executive Function-Adult Version at Week 8
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 day before starting the intervention and 1 day after finishing the intervention

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
Background: PubMed 18548835Bastien 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.
Background: PubMed 15600224Bastien CH, Vallieres A, Morin CM. Precipitating factors of insomnia. Behav Sleep Med. 2004;2(1):50-62. doi: 10.1207/s15402010bsm0201_5.
Background: PubMed 22467988Corsi-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.
Background: PubMed 11752485Espie 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.
Background: PubMed 23577218Haimov 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.
Background: PubMed 12186352Harvey AG. A cognitive model of insomnia. Behav Res Ther. 2002 Aug;40(8):869-93. doi: 10.1016/s0005-7967(01)00061-4.
Background: PubMed 21967449Harvey 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.
Background: PubMed 28453603Aasvik 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.
Background: PubMed 25364074Fortier-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.
Background: PubMed 32005351Brownlow 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.
Background: PubMed 29448003Leerssen 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.
Background: PubMed 9358396Perlis 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.
Individual participant dataSharing planned: No. Due to the institutional restrictions that regulate the data protection of patients in the Spanish public health system, it is not possible for the investigators to share any individual participant data.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jon A Duñabeitia study director

Universidad Nebrija

Jose L Tapia principal investigator

Univerisdad Nebrija

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Personalized cognitive stimulation in people with Insomnia and Insomnia Type; Sleep Disorder, run by Universidad Antonio de Nebrija at 1 site in Spain.

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 12 inclusion and 7 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 3 Nov 2022. 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 Spain. 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?

Change from Baseline in Sleep quality on the Pittsburgh Sleep Quality Index at Week 8 (time frame: 1 day before starting the intervention and 1 day after finishing the intervention). The study lists 3 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 NCT05050292, which also lists 16 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 3 Nov 2022.