NCT05050292

Cognitive Stimulation and Sleep Quality. An Innovative Intervention for Insomnia

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Universidad Antonio de Nebrija · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia
• Insomnia Type; Sleep Disorder

Interventions

Type	Name	Description
OTHER	Personalized cognitive stimulation	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.
OTHER	Sham cognitive stimulation	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.

Timeline

• Start date: 2021-10-04
• Primary completion: 2023-03-16
• Completion: 2023-03-16
• First posted: 2021-09-20
• Last updated: 2022-11-03

Locations

1 site across 1 country: Spain