Back to resultsCognitive Stimulation and Sleep Quality. An Innovative Intervention for Insomnia
Primary Purpose
Insomnia, Insomnia Type; Sleep Disorder
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Personalized cognitive stimulation
Sham cognitive stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Cognitive stimulation, Cognitive intervention, Sleep disorder, Sleep quality
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:
- 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.
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.
Sites / Locations
- Hospital Universitario de la Ribera
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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).
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).
Secondary Outcome Measures
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
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).
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).
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).
Full Information
NCT ID
NCT05050292
First Posted
September 6, 2021
Last Updated
November 2, 2022
Sponsor
Universidad Antonio de Nebrija
Collaborators
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
1. Study Identification
Unique Protocol Identification Number
NCT05050292
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
March 16, 2023 (Anticipated)
Study Completion Date
March 16, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Antonio de Nebrija
Collaborators
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Insomnia Type; Sleep Disorder
Keywords
Insomnia, Cognitive stimulation, Cognitive intervention, Sleep disorder, Sleep quality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Personalized cognitive stimulation
Other Intervention Name(s)
CogniFit's personalized brain training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham cognitive stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Sleep quality on the Pittsburgh Sleep Quality Index at Week 8
Description
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).
Time Frame
1 day before starting the intervention and 1 day after finishing the intervention
Title
Change from Baseline in Insomnia on the Insomnia Severity Index at Week 8
Description
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).
Time Frame
1 day before starting the intervention and 1 day after finishing the intervention
Title
Change from Baseline in Quality of life on Measuring Quality of Life | The World Health Organization - abridged version
Description
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).
Time Frame
1 day before starting the intervention and 1 day after finishing the intervention
Secondary Outcome Measure Information:
Title
Change from Baseline in Executive function on Behavior Rating Inventory of Executive Function-Adult Version at Week 8
Description
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
Time Frame
1 day before starting the intervention and 1 day after finishing the intervention
Title
Change from Baseline in Depressive symptoms on The Beck Depression Inventory-II at Week 8
Description
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).
Time Frame
1 day before starting the intervention and 1 day after finishing the intervention
Title
Change from Baseline in Anxiety symptoms on the State-Trait Anxiety Inventory at Week 8
Description
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).
Time Frame
1 day before starting the intervention and 1 day after finishing the intervention
Title
Change from Baseline in worrying on The Penn State Worry Questionnaire at Week 8
Description
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).
Time Frame
1 day before starting the intervention and 1 day after finishing the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon A Duñabeitia
Organizational Affiliation
Universidad Nebrija
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jose L Tapia
Organizational Affiliation
Univerisdad Nebrija
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de la Ribera
City
Alzira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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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Cognitive Stimulation and Sleep Quality. An Innovative Intervention for Insomnia
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