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Sleep Intervention + CBT for Insomnia
N/A
Recruiting
Led By Catherine Siengsukon, PT, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Report of difficulty falling asleep, maintaining sleep, or waking up too early at least three nights a week for the past six months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and one-year assessment
Awards & highlights
Study Summary
This trial is testing whether a sleep intervention can improve cognitive function in older adults with insomnia symptoms, and whether it can reduce the rate of Aβ accumulation as measured by PET imaging.
Who is the study for?
Adults aged 60-85 with insomnia symptoms, who have trouble sleeping at least three nights a week for six months and score high enough on mental state exams to show no severe cognitive impairment or dementia. Excluded are those with untreated sleep disorders, severe depression, substance abuse history, certain mental illnesses or learning disabilities, current shift workers, or those already in CBT-I treatment.Check my eligibility
What is being tested?
The trial is testing whether a six-week program of Sleep and Lifestyle Education combined with Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve cognitive function and reduce brain amyloid deposits in older adults with insomnia. Some participants will also undergo PET imaging to track changes in amyloid levels over one year.See study design
What are the potential side effects?
While the study does not involve medication that typically has side effects, interventions like CBT-I may cause temporary increases in anxiety or stress due to changes in sleep patterns as individuals adjust to new behaviors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had trouble sleeping at least three nights a week for the past six months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6-week reassessment, and one-year reassessment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6-week reassessment, and one-year reassessment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Continuous Performance Test (CPT)
Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
+1 moreSecondary outcome measures
Polysomnography
Other outcome measures
Apolipoprotein E (APOE) 4 Genotyping
Coin in Hand
Florbetapir PET Imaging
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Six-Week CBT-I ProgramExperimental Treatment1 Intervention
CBT-I, six sessions, forty-five to sixty minutes in duration.
Session 1: set up sleep restriction and stimulus control, discuss strategies for how to stay awake to a prescribed hour and what to do with wake after onset sleep time, provide sleep hygiene education.
Session 2: determine if upward titration of total sleep time is warranted, review sleep hygiene.
Session 3: continue upward titration of total sleep time, cognitive therapy for negative sleep beliefs if indicated.
Session 4: continue upward titration of total sleep time, follow-up regarding negative sleep beliefs.
Session 5: continue upward titration of total sleep time, discuss relapse prevention.
Session 6: assess global treatment gains, discuss questions regarding relapse prevention.
Group II: Six-Week Sleep and Lifestyle Education ProgramActive Control1 Intervention
Sleep and Lifestyle Education, six sessions, forty-five to sixty minutes in duration.
Session 1: Sleep education, Instruction/demonstration on stretching exercises.
Session 2: Education on environmental factors & sleeping positions that impact sleep.
Session 3: Education on lifestyle factors that impact sleep.
Session 4: Education on diet and sleep.
Session 5: Education on exercises and sleep.
Session 6: Discus maintaining achievements & preventing relapses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia (CBT-I)
2014
N/A
~720
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
467 Previous Clinical Trials
169,058 Total Patients Enrolled
2 Trials studying Insomnia
71 Patients Enrolled for Insomnia
National Institute on Aging (NIA)NIH
1,690 Previous Clinical Trials
28,026,931 Total Patients Enrolled
9 Trials studying Insomnia
1,575 Patients Enrolled for Insomnia
National Institutes of Health (NIH)NIH
2,715 Previous Clinical Trials
7,510,198 Total Patients Enrolled
10 Trials studying Insomnia
918 Patients Enrolled for Insomnia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had trouble learning or paying attention in the past.I am currently taking medication or supplements for sleep problems.I have an untreated sleep disorder like sleep apnea or restless leg syndrome.You did not pass a test for seeing things up close using a special chart.You have had problems with drugs or alcohol in the past two years according to specific guidelines.I have had trouble sleeping at least three nights a week for the past six months.You have a score of 10 or more on the Insomnia Severity Index.You have a score of 25 or higher on the Mini-Mental State Examination (MMSE).You currently work night shifts or have worked night shifts in the past.I am currently undergoing cognitive behavioral therapy for insomnia.You have a high score on the Patient Health Questionnaire (PHQ-9) showing severe depression or have had thoughts about harming yourself.You have a serious mental illness like schizophrenia or bipolar disorder.You have a score of 10 or more on the Insomnia Severity Index.You scored less than or equal to two on a test for memory and thinking skills.I cannot hear when people talk in a normal voice.You have a score of 25 or higher on the Mini-Mental State Examination (MMSE).I have a history of a nervous system disorder like stroke or Parkinson's.
Research Study Groups:
This trial has the following groups:- Group 1: Six-Week CBT-I Program
- Group 2: Six-Week Sleep and Lifestyle Education Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Insomnia Patient Testimony for trial: Trial Name: NCT03954210 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the capacity for enrolment in this clinical trial?
"Indeed, the records hosted on clinicaltrials.gov indicate that this medical research is presently searching for participants. The trial was initially unveiled on August 27th 2019 and its latest update occurred November 1st 2022. This study requires 200 patients to be enrolled at a single location."
Answered by AI
Is enrollment underway for this research study?
"According to clinicaltrials.gov, this medical study is currently sourcing participants after its initial posting on August 27th 2019 and subsequent update on November 1st 2022."
Answered by AI
What population is eligible for participation in this medical experiment?
"This research endeavour is currently looking for 200 seniors (aged between 60 and 85) to participate. To qualify, applicants must have a score of 25 or higher on the Mini-Mental State Examination (MMSE), experience difficulty falling asleep/staying asleep/waking up too early at least three times per week over the past six months; achieve a mark of 10 or more on the Insomnia Severity Index and be rated as 2 or lower according to Dementia Screening Interview (AD8)."
Answered by AI
Is the age of seventy a barrier to enrollment in this research initiative?
"This clinical trial is recruiting elderly individuals, who must be aged between 60 and 85 years."
Answered by AI
Who else is applying?
What state do they live in?
Kansas
New Hampshire
What site did they apply to?
University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Saw the stuff & would love to find a way to get better sleep. I am hoping CBT will help me to have restful sleep rather than taking medication.
PatientReceived no prior treatments
I am currently on medication to go to sleep, but I wake up every 2 to 3 hours during the night. I am as exhausted when I get up as I am before going to sleep. I now take modafinil during the day to stay awake. This is no way to live!
PatientReceived no prior treatments
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