Enhanced CBTi for Older Adult Sleep and Cognition
Condition: Insomnia; Alzheimers Disease Related Dementias
MeSH terms: Alzheimer Disease; Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This randomized clinical trial on 60+ aged and independent-living healthy individuals with
      symptoms of insomnia will attempt to improve sleep and health outcomes related to sleep with
      enhancement of a clinical intervention, Cognitive Behavioral Therapy for Insomnia (CBTi).
    

Detailed description: 
      Telehealth-delivered enhanced CBTi (integrated with a sleep diary app, a therapist dashboard,
      and data from IoT devices) will be compared to standard telehealth CBTi and to usual
      treatment with sleep hygiene education. The investigators will determine effects on insomnia
      (primary outcome) and on clinical sleep metrics (secondary outcome), among other outcomes
      including cognitive performance, blood biomarkers of ADRD, and therapeutic adherence.

      After screening consent and qualification, informed consent, and adherence evaluation with
      ambulatory devices (1wk), study participants are pseudo-randomized into one of 3 study arms
      (2:2:1, Enhanced CBTi : Standard CBTi : Sleep Hygiene). The living space of participants is
      equipped with IoT data collection devices. Participants take surveys related to sleep, have
      blood drawn, wear ambulatory devices, complete cognitive evaluations, and interact with
      nearable living space devices and an iPhone interface during a preparation week leading up to
      an intake telehealth appointment. Baseline data collection (1wk) occurs. Participants then
      adhere to behavioral therapy directives prescribed at weekly telehealth sessions with a
      clinically qualified therapist, take surveys related to sleep, complete cognitive
      evaluations, wear ambulatory devices, and interact with nearable living space devices and an
      iPhone interface throughout the study intervention period of 6 weeks. During the final week
      (coinciding with the 6th intervention week), participants have a second blood draw and return
      all study equipment/devices at the conclusion of participation.
    

Intervention name(s): CBTi with Application; CBTi; Sleep Hygiene Education
Intervention type(s): Combination Product; Behavioral; Behavioral
Intervention description(s): Participants randomized to this study arm will experience an attempted enhancement of standard video conferencing CBTi, that is facilitated with electronic device-based data and resources to the clinician. Noninvasive ambulatory worn and nearable devices deliver feedback of data to the clinician on an application interface. This information will be used to inform the therapeutic approach and to facilitate a living-space environment that is conducive to effective therapy.; Participants randomized to this study arm will experience standard CBTi that is delivered via video conferencing by a clinician, with some application interface use.; Participants randomized to this study arm will experience sleep hygiene education and training, with some application interface use.
Other intervention name(s): Cognitive-Behavioral Therapy for Insomnia - Enhanced; Cognitive-Behavioral Therapy for Insomnia - Standard
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: CBTi with Application, Standard TeleHealth CBTi, and Sleep Hygiene Education study groups run in parallel after randomization.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cognitive-behavioral therapy (CBT); sleep; ADRD; insomnia