Clinical Trials Logo
  1. Home
  2. Insomnia
  3. NCT05015803

Enhanced CBTi for Older Adult Sleep and Cognition — R44  

Insomnia Clinical Trial

Official title:
A Non-pharmacological Multi-modal Therapy to Improve Sleep and Cognition and Reduce Mild Cognitive Impairment Risk

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05015803
Study type Interventional
Source Penn State University
Contact
Status Completed
Phase Phase 2/Phase 3
Start date March 16, 2022
Completion date August 16, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT05963542 - Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia N/A
Completed NCT06339853 - Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia N/A
Recruiting NCT04069247 - Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia N/A
Completed NCT04493593 - Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility N/A
Recruiting NCT06278077 - Neurexan - a Clinical Trial in Short-Term Insomnia Patients Phase 2
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT04661306 - The Better Sleep for Supporters With Insomnia Study N/A
Recruiting NCT06207279 - Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Recruiting NCT06006299 - Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC) N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Completed NCT04564807 - Testing an Online Insomnia Intervention N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04035200 - Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation Phase 2
Active, not recruiting NCT05027438 - Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention N/A
Recruiting NCT06053840 - An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia Phase 4
Not yet recruiting NCT06348082 - Project Women's Insomnia Sleep Health Equity Study (WISHES) N/A
Not yet recruiting NCT06363799 - Osteopathic Protocol for Insomnia in College Students N/A
Not yet recruiting NCT05991492 - Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application N/A
Not yet recruiting NCT06025968 - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis N/A