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

Abstract

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.

Keywords: PROTECT Norge; cognitive behavioral therapy for insomnia; eHealth; insomnia symptoms; older adults; randomized controlled trial; sleep intervention.