Sleep disruptions are a hallmark and consequence of Post-traumatic Stress Disorder (PTSD) and Traumatic Brain Injury (TBI), and a risk factor for suicide. In veterans, sleep disruptions, such as nightmares, are often the most burdensome aspects of PTSD. Improving sleep often improves other PTSD and TBI symptoms.
Insomnia and CBT-I. The first line treatment for insomnia is cognitive behavioral treatment (Cognitive Behavioral Treatment of Insomnia, CBT-I), a non-pharmacological therapeutic program that targets thoughts and behaviors that cause or worsen sleep problems. CBT-I is very effective according to a study of veterans within the Veterans Health Administration (VHA). CBT-I can be delivered through telehealth, which can increase availability of treatment. Veterans with PTSD are overwhelmingly prescribed sedative-hypnotics despite CBT-I being recommended as the first line treatment for insomnia by the Department of Veterans Affairs and other agencies.
- Access to trained CBT-I specialists is limited
- CBT-I is not standardized across different practices
- CBT-I is based on subjective sleep data obtained through sleep diaries and other self-report measures, which have inherent limitations
To improve sleep, researchers must measure it. Sleep is often measured subjectively via a diary, but how people think they are sleeping versus how they are actually sleeping differs. To objectively record sleep researchers often rely on having subject participate in an overnight stay in a sleep laboratory where they can be monitored via an electroencephalogram (EEG). However, this means sleeping hooked up to electrodes in an unfamiliar environment. It is not surprising that sleep in a laboratory often does not reflect how people sleep at home. Additionally, this process is a very expensive and only provides data for a few nights, at best.
Sleepwell, a digital-health, precision-medicine approach to improving sleep associated with brain disorders.
The SleepWell research program was established to improve methods to measure sleep and develop precision therapeutics that are user-friendly, cost-effective and reliable.
The goal is to develop a personalized CBT-I that is precise and adaptive.
Sleepwell was recognized as “Best Sleep Monitoring Solution” by the 2019 MedTech Breakthrough Awards program. MedTech Breakthrough Awards honor excellence and innovation across health and medical technology.
The Value of Objective Data
CBT-I is based on subjective sleep data obtained through sleep diaries and other self-report measures, which has limitations such as inaccuracy of sleep perceptions, increased clock-watching and low adherence to daily monitoring in some patients. Objective data on sleep obtained in the home setting can reveal aspects of sleep/wake patterns that may not be detected by self-report such as the exact time, number and duration of awakenings during the night.
Objective data could also detect comorbidities that would affect sleep quality, such as disordered breathing or parasomnias that might necessitate adaptations to CBT-I. Finally, objective data could be used to track adherence to CBT-I.
Digital health allows researchers to study brain health and disease in unprecedented ways. Wearable technologies hold promise in the assessment and continuous monitoring of patients to better screen and diagnose symptoms, monitor disease progression, and observe intervention response or lack thereof. By tracking variables such as sleep, physical activity, stress and cognition, we may be able to better understand changes over time – and develop preventive diagnostics and treatments that make a difference in patients’ lives.
Over the last 2 years, we have been developing a digital health platform, offering the ability to monitor, record, and analyze how people sleep at home, using wearable and home-sensor devices and Cognitive Behavioral Therapy for insomnia (CBT-i).
CBT-i is a short program (6 weeks) that can be administered through telehealth and teaches a set of behavioral tips to improve sleep. CBT-i has been shown to be more effective than sleep medication and can offer a behavior change for an extended period.
Wearable and home-sensor devices will be used to capture real-time objective data in the home setting.
The Clinician Dashboard component of the platform allows sleep therapists to visualize the data from their patients and to tailor a program aimed at improving sleep for the individual patient.
Sleepwell’s tailored focus on data analysis and development of disease-related algorithms from behavioral, cognitive, physiological and contextual data can be used to quantify brain health, improving clinicians’ ability to diagnose a wide variety of brain disorders and understand a patient’s unique experiences and tailor treatment accordingly.
A key aspect of the Sleepwell Platform is validation. It is essential the devices used to record sleep at home are accurate. However, the selection process of which devices to use is not simple. In CVB’s EarlySignal device lab, we test different combinations of devices and evaluate their utility to ensure effectiveness and accuracy.
CVB is planning a Technical Performance Verification study to test a series of devices for accuracy against the gold standard (Polysomnography) in subjects with PTSD and insomnia. Study results will be instrumental for the next step, which is to integrate the Patient Diary with Wearables & Sensors to the Clinician Dashboard and study the best ways to personalize and effectively restore sleep using the telehealth form of CBT-i.
Sleepwell Consortium Members
- Healios, Inc.
- Cohen Veterans Bioscience, Inc.