Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-29 @ 4:17 PM
Study NCT ID:
NCT05050292
Status:
UNKNOWN
Last Update Posted:
2022-11-03
First Post:
2021-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Stimulation and Sleep Quality. An Innovative Intervention for Insomnia
Sponsor:
Universidad Antonio de Nebrija
Organization:
Study Overview
Official Title:
Cognitive Stimulation Intervention Program for Insomniacs and Its Benefit on Sleep Quality, Executive Functions and Quality of Life
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: