Deep Sleep in Older Adults

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorProactive Life Inc

About this trial

This double blind randomized clinical trial on older independent-living healthy individuals with symptoms of insomnia will harness Cognitive Behavioral Therapy for Insomnia (CBT-I) and augment it with ambulatory data collection devices, personalized digital content, and smart sound and light cues (CBT-I +Internet of Things \[IoT\]+Artificial Intelligence \[AI\]). With this approach, the investigators aim to overcome many of the limitations that CBT-I in the clinic faces: the investigators can implement it in ambulatory settings while providing increased (remote) accessibility to therapy. The investigators will compare the CBT-I +IoT+AI to active controls that also integrate with smart phone devices, including SleepEZ, which is also based on CBT-I, and sleep hygiene education. These active controls will help determine whether CBT-I +IoT+AI is effective at treating insomnia based on the Insomnia Severity Index (ISI) (primary outcome), sleep metrics (secondary outcome), cognitive performance (secondary outcome), and additional outcomes like therapeutic adherence and other mental health assessments. Participants will be asked to track sleep with wearable and nearable devices, complete surveys, and complete cognitive assessments.

Eligibility criteria

Qualifiers

Fluent English speaker and reader.

Capable of providing one's own informed consent.

As determined by validated, abbreviated phone-based remote Montreal Cognitive Assessment (MoCA) testing score of ≥18, which is the score that separates Mild Cognitive Impairment (MCI) from Alzheimer's Disease and Related Dementia (ADRD).

Age 65+ years old (inclusive) at enrollment, but if recruitment is slow, the investigators may adjust the criteria to 60+, and if it is still slow, it could go as low as 55+ years old.

Disqualifiers

Illicit drug use in the past month (except for marijuana because it is legal in many States, and the investigators are recruiting nationwide).

Diagnosed serious mental health disorder.

Specifically, psychosis or bipolar depression, severe major depression, moderate to high risk of suicide, dementia

As self-reported on screening survey

Trial design

Treatments tested in this trial

  • CBT-I-IoT-AI
  • SleepEZ CBTi
  • Sleep Hygiene IoT

Treatment groups

180 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Proactive Life Inc

Lead sponsor

National Institute on Aging (NIA)

Collaborator