CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03954210
NCT03954210N/ACompleted

SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid

University of Kansas Medical Center·interventional·Posted May 17, 2019·Updated Mar 27, 2026

In Brief

A clinical study evaluating Cognitive Behavioral Therapy for Insomnia (CBT-I) and Sleep and Lifestyle Education for Insomnia. Completed, enrolled 200 participants across 1 site.

Detailed Summary

The objective of this study is to compare the efficacy of a sleep intervention on improving cognitive function in older adults with symptoms of insomnia, determine the association between change in sleep measures and change in cognitive function, and examine the efficacy of the sleep intervention on reducing the rate of Aβ deposition. Participants, ages 60-85, will be randomly assigned to a six-week sleep intervention program. A sub-group of fifty participants will undergo Florbetapir-Positron-emission tomography (PET) imaging during the one-year reassessment to examine the efficacy of the sleep intervention on reducing the rate of Aβ accumulation from baseline to one-year post-intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 17, 2019
Enrollment StartAug 27, 2019
Primary CompletionApr 18, 2025
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 7.1 years ago

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I)behavioral

CBT-I is an in-person, one-on-one program with a graduate psychology research assistant who is trained in providing a standardized CBT-I. Participants will maintain a sleep diary during the course of the program to aid in tailoring the program. Each session will begin with a summary and graphing of sleep diary data and will include an assessment of treatment gains and adherence.

Sleep and Lifestyle Educationbehavioral

Participants in the sleep and lifestyle education group will attend six weekly, in-person, one-on-one, stretching, and thinking activity sessions with a graduate research assistant to control for socialization and contact with research personnel.