Preventing and Treating Insomnia Symptoms in Midlife and Older Adults (ASLEEP): Protocol for a Randomized Controlled Trial Using the PROTECT Norge Infrastructure.

BACKGROUND

Sleep is increasingly recognized as a fundamental determinant of health and brain function. Sleep difficulties are common in older adults, with a substantial proportion reporting problems initiating or maintaining sleep, which can negatively affect mental and physical health, cognitive function, and quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is the gold-standard treatment for insomnia disorder; however, its reach is limited due to resource demands and a shortage of professionals that can deliver it. Digitally delivered CBT-I via eHealth platforms increases accessibility and has demonstrable effects but remains limited in many countries.

OBJECTIVE

The objective of this paper is to describe the protocol for the further development and evaluation of ASLEEP (Preventing and Treating Insomnia Symptoms in Midlife and Older Adults), a tiered, digitally delivered CBT-I intervention designed to reduce insomnia severity and improve related health outcomes in adults aged 50 years and older.

METHODS

The project will be conducted in 2 phases. Phase 1 focuses on refining and optimizing ASLEEP, developing an advanced CBT-I course, and integrating a nested trial into PROTECT (Platform for Research Online to investigate Cognition and Genetics in Ageing) Norge, a fully automated digital research platform. Phase 2 is a fully digital, 2-arm, waitlist-controlled randomized controlled trial, with 400 participants randomized 1:1 to the intervention or waitlist control and allocation stratified by age and insomnia severity. Outcomes will be assessed at baseline and at 3, 6, and 12 months, with a 15-month follow-up for the waitlist group. The primary outcome is insomnia severity measured by the Insomnia Severity Index. Secondary outcomes include sleep medication use, depression, anxiety, and cognition.

RESULTS

The project started in January 2026, with funding awarded. As of February 2026, phase 1-intervention optimization and development-is underway. Ethics approval for ASLEEP has not been submitted. Following completion of phase 1, phase 2, which includes a digital randomized controlled trial, will commence; as of February 2026, no participants have been recruited, and data collection and data analysis have not yet started. Short-term data collection is planned to be completed by summer 2028, with results disseminated in winter 2028.

CONCLUSIONS

This trial will evaluate the short- and long-term effectiveness of a tiered digital CBT-I intervention for midlife and older adults. By leveraging the PROTECT Norge platform and if effective, ASLEEP may represent a scalable model for low-threshold, accessible prevention and treatment of symptoms of insomnia.