Deep Sleep in Older Adults
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55+
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
This trial does not accept healthy volunteersQualifiers
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 55+ years old (inclusive) at enrollment. a. As self-reported on screening survey and later verified in video appointment (e.g. Zoom Health)
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
Design model
Parallel
Treatments tested in this trial
SleepSpaceRx CBT-I-IoT-AI
BehavioralWhat distinguishes this condition is increased customization of the CBT-I content and increased usage of the Internet of Things (IoT) devices used to promote CBT-I directives.
SleepEZ CBTi
BehavioralThis condition includes interactive videos about CBT-I and leverages some IoT interventions.
Sleep Hygiene IoT
BehavioralThis intervention includes intractive videos regarding sleep hygiene, a component of CBT-I and leverages some IoT interventions.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: SleepSpaceRx CBT-I-IoT-AIExperimental treatment 1 intervention
Group B: Sleep-EZ CBT-I Based SolutionActive comparator 1 intervention
Group C: Sleep Hygiene + IoTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Insomnia Severity Index (ISI)
Subjective patient completion of the Insomnia Severity Index survey. Sum of survey item responses; Minimum score: 0; Maximum score: 28. Higher sum score indicates a greater number of, or more severe, insomnia symptoms; reduction in sum score suggests improvement of insomnia.
Time frame
Weekly for the first 8 weeks, then at week 10 and week 12Secondary outcomes
1
Change in cognitive test battery performance
Objective test performance metrics on an ambulatory cognitive test battery delivered with a smartphone device that includes validated assessments: the Mobile Monitoring of Cognitive Change (M2C2) and DANA Brain Vitals.
Time frame
Daily for two weeks at baseline and two weeks post treatment2
Consensus Sleep Diary
Subjective sleep diary data will be used to determine perceived sleep features (duration, quality, time in bed, etc).
Time frame
Daily for the first eight weeks of the trialOther outcomes
1
Nearable Sleep Sensing (Motion)
Motion (up to 50 hertz x, y, z actigraphy) from the iPhone will be used to estimate time in bed, sleep/wake, sleep onset latency, wake after sleep onset, and other sleep related metrics.
Time frame
Daily from week two to week eight2
Nearable Sleep Sensing (Sound)
Sound data (decibels) from the iPhone will be used to estimate time in bed, sleep/wake, sleep onset latency, wake after sleep onset, and other sleep related metrics.
Time frame
Daily from week two to week eight3
Wearable Sleep Sensing (Motion)
Motion (up to 50 hertz x, y, z actigraphy) from the Apple Watch will be used to estimate time in bed, sleep/wake, sleep onset latency, wake after sleep onset, and other sleep related metrics.
Time frame
Daily from week two to week eight4
Wearable Sleep Sensing (Heart Rate)
Heart rate (up to .2 hertz) from the Apple Watch will be used to estimate time in bed, sleep/wake, sleep onset latency, wake after sleep onset, and other sleep related metrics.
Time frame
Daily from week two to week eightSponsors and contacts
Click on the lead sponsor to view all of their trials.
Proactive Life Inc
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov