InsomniaPhase 2/3R44NCT05015803

Enhanced CBTi for Older Adult Sleep and Cognition

A Phase 2/3 study testing CBTi with Application, CBTi and Sleep Hygiene Education in people with Insomnia and Alzheimers Disease Related Dementias, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 60 to 90 years
Conditions the study is for: Insomnia, Alzheimers Disease Related Dementias
What is being tested?: CBTi with Application, CBTi and Sleep Hygiene Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 16 Mar 2022to 16 Aug 2023
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Fluent English speaker/reader
Resident of the state/commonwealth of Pennsylvania for tax purposes
Ability to complete (sign) own consent form
Age 60-90 (inclusive, at enrollment)
Independent Living status (or equivalent; if dwelling in a community living facility)
Insomnia Severity Index (ISI) screening survey score of >=11

Show all 9Show fewer

Willing to refrain from initiating new therapeutic insomnia interventions that are not a part of this study protocol for the duration of study participation
Willing to maintain existing physician-directed intervention for issues pertaining to sleep for the duration of study participation
Has a residence with access to WiFi

Who cannot join

Has a pacemaker
Illicit drug use in the past month
Diagnosed serious mental health disorder (e.g. psychosis or bipolar depression)
Currently engaged in evidence-based psychotherapy for Insomnia (e.g. CBTi)
Cohabiting with a current or previous participant in this study
Evidence of Cognitive Impairment (a score of <18 on the abbreviated Montreal Cognitive Assessment [MoCA] screening evaluation)

Trial locations and contacts

1 site in 1 country.

United States1 site

The Pennsylvania State University
University Park, Pennsylvania, 16802

Other trials in United States

About this study

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

Read the 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.

Conditions: Insomnia, Alzheimers Disease Related Dementias
Being tested: CBTi with Application, CBTi, Sleep Hygiene Education
Keywords: cognitive-behavioral therapy (CBT), sleep, ADRD, insomnia
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBTi with ApplicationCombination product
Also called Cognitive-Behavioral Therapy for Insomnia - Enhanced
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.
CBTiBehavioural
Also called Cognitive-Behavioral Therapy for Insomnia - Standard
Participants randomized to this study arm will experience standard CBTi that is delivered via video conferencing by a clinician, with some application interface use.
Sleep Hygiene EducationBehavioural
Participants randomized to this study arm will experience sleep hygiene education and training, with some application interface use.

Study groups in NCT05015803
Study group	Role	What they receive
CBTi with Application	Experimental	Device-based intervention facilitation and clinician interfacing for Cognitive Behavioral Therapy for Insomnia (CBTi). Receives: Combination Product: CBTi with Application
CBTi	Active comparator	Standard CBTi delivered via video conferencing [Zoom Health]. Receives: Behavioral: CBTi
Sleep Hygiene	Active comparator	Treatment as usual: Sleep hygiene education and training. Receives: Behavioral: Sleep Hygiene Education

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Insomnia Severity Index
Subjective patient completion of the Insomnia Severity Index survey. Sum of survey item responses; Minimum score: 0; Maximum score: 28. Higher sum score indicates a greater number of, or more severe, insomnia symptoms; reduction in sum score suggests improvement of insomnia.
Measured: Screening (at enrollment qualification) and Weekly (each of study weeks 1-8)

Secondary outcomes (3)

Change in Sleep Maintenance Efficiency
Objective ambulatory activity (actigraphy) and other biometric data will be collectively used to determine sleep state. From sleep state data, Sleep Maintenance Efficiency will be calculated (i.e. percentage of time between sleep onset and awakening for the main sleep period that is spent in the sleep state). Minimum score: 0% (i.e. no sleep); Maximum score: 100% (i.e. no awake time during the sleep window). Higher percentage score indicates that a greater proportion of the rest interval was spent actually asleep; increase in percentage score suggests improvement in sleep quality.
Measured: Nightly (each night throughout study weeks 1-8)
Change in Total Sleep Time
Objective ambulatory activity (actigraphy) and other biometric data will be collectively used to determine sleep state. From sleep state data, Total Sleep Time will be calculated (i.e. total minutes of nocturnal sleep). An increase in sleep time indicates improvement in sleep quantity.
Measured: Nightly (each night throughout study weeks 1-8)
Change in Self-Reported Sleep
Subjective sleep diary data will be used to determine perceived sleep features (duration, quality, etc).
Measured: Daily (each morning throughout study weeks 1-8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 202216 Aug 2023

First posted20 Aug 2021
Study start16 Mar 2022
Primary completion14 Jun 2023
Study completion16 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by Penn State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: CBTi with Application, Standard TeleHealth CBTi, and Sleep Hygiene Education study groups run in parallel after randomization.
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05015803
Sponsor's protocol ID: R44AG056250
Acronym: R44
Status last verified: Apr 2024
First submitted: 16 Jul 2021
Last updated: 12 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
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Treating Insomnia in Mild Cognitive Impairment
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The Effects of Orexin Antagonism on Fear Extinction in PTSD
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A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia in a Randomized, Controlled, Dose-finding Study
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Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-pharmacological Multi-modal Therapy to Improve Sleep and Cognition and Reduce Mild Cognitive Impairment Risk
ClinicalTrials.gov ID: NCT05015803
Acronym / sponsor ID: R44 / R44AG056250
Conditions: Insomnia, Alzheimers Disease Related Dementias
Keywords: cognitive-behavioral therapy (CBT), sleep, ADRD, insomnia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Penn State UniversityUniversity, hospital or other
Collaborators: University of Arizona, Proactive Life Inc
Study start: 16 Mar 2022 (actual)
Primary completion: 14 Jun 2023 (actual)
Study completion: 16 Aug 2023 (actual)
First posted: 20 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3
Model description: CBTi with Application, Standard TeleHealth CBTi, and Sleep Hygiene Education study groups run in parallel after randomization.

Arm	Type	Receives
CBTi with Application	Experimental	Combination Product: CBTi with ApplicationDevice-based intervention facilitation and clinician interfacing for Cognitive Behavioral Therapy for Insomnia (CBTi).
CBTi	Active comparator	Behavioral: CBTiStandard CBTi delivered via video conferencing [Zoom Health].
Sleep Hygiene	Active comparator	Behavioral: Sleep Hygiene EducationTreatment as usual: Sleep hygiene education and training.

Who may qualify

Ages: 60 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Fluent English speaker/reader
Resident of the state/commonwealth of Pennsylvania for tax purposes
Ability to complete (sign) own consent form
Age 60-90 (inclusive, at enrollment)
Independent Living status (or equivalent; if dwelling in a community living facility)

Key exclusion criteria (6 listed)

Has a pacemaker
Illicit drug use in the past month
Diagnosed serious mental health disorder (e.g. psychosis or bipolar depression)
Currently engaged in evidence-based psychotherapy for Insomnia (e.g. CBTi)
Cohabiting with a current or previous participant in this study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CBTi with ApplicationAlso: Cognitive-Behavioral Therapy for Insomnia - EnhancedParticipants 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.	Combination product	CBTi with Application
CBTiAlso: Cognitive-Behavioral Therapy for Insomnia - StandardParticipants randomized to this study arm will experience standard CBTi that is delivered via video conferencing by a clinician, with some application interface use.	Behavioural	CBTi
Sleep Hygiene EducationParticipants randomized to this study arm will experience sleep hygiene education and training, with some application interface use.	Behavioural	Sleep Hygiene

Primary outcome

Change in Insomnia Severity Index
Time frame: Screening (at enrollment qualification) and Weekly (each of study weeks 1-8)
Subjective patient completion of the Insomnia Severity Index survey. Sum of survey item responses; Minimum score: 0; Maximum score: 28. Higher sum score indicates a greater number of, or more severe, insomnia symptoms; reduction in sum score suggests improvement of insomnia.

3 secondary outcomes

Change in Sleep Maintenance Efficiency
Time frame: Nightly (each night throughout study weeks 1-8)
Change in Total Sleep Time
Time frame: Nightly (each night throughout study weeks 1-8)
Change in Self-Reported Sleep
Time frame: Daily (each morning throughout study weeks 1-8)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
Individual participant dataSharing planned: No

Related trials for Insomnia

Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
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Not yet recruitingPhase 2
A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia in a Randomized, Controlled, Dose-finding Study
Chronic Insomnia
Active, not recruiting
Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel Taylor, Ph.D. principal investigator

The University of Arizona

Daniel Gartenberg, Ph.D. principal investigator

Sleep Space, Inc.

Orfeu M Buxton, Ph.D. principal investigator

The Pennsylvania State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Insomnia Severity Index (time frame: Screening (at enrollment qualification) and Weekly (each of study weeks 1-8)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05015803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.