Poor Quality SleepNCT04583033
Sleep Well for Healthy Brain
A study testing Cognitive Behavioral Therapy (CBT) in people with Poor Quality Sleep, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to slow down the aging of the participant's brain by improving sleep quality. Read more about this study
- Who is it for?
- Ages 55 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poor Quality Sleep
- What is being tested?
- Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2021to 31 Oct 2023
- Phase
- Interventional
- 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 55 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking healthy subjects age 55 years and older capable and willing to consent to participate in the study. In addition, subject should be cognitively normal and have well documented sleep issues that results with poor sleep quality based on self-reported assessment.
Who cannot join
- pregnant women
- cognitively impaired subjects not able to provide consent
- prisoners
- Subjects 55 years of age and older that meet criteria for mild cognitive impairment.
- Subjects with any neurological disorder.
- Any other condition that in the opinion of the investigator may affect the participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lifestyle Stressors of Hippocampus and Alzheimer's Disease (AD) Related Brain Regions: Potential for Intervention
The purpose of this study is to slow down the aging of the participant's brain by improving sleep quality.
- Conditions
- Poor Quality Sleep
- Being tested
- Cognitive Behavioral Therapy (CBT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
Treatment components include stimulus control, sleep restriction therapy, relaxation, and cognitive therapy. Each session will last approximately one hour and will be provided on line.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) Group | Experimental | Participants will receive CBT intervention bi-weekly for total of six (6) sessions. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| Control Group | No intervention | Participants will not receive any intervention as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of brain tissue volume loss in specific brain regions
As evaluated from the Magnetic Resonance Imaging (MRI) Brain scan
Measured: Year 2
Secondary outcomes (1)
Cognitive Performance
Cognitive performance will be assessed using a Memory test which has a composite score ranging from 80 to 120 % with a higher score indicating better performance and a midrange at 100%.
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start28 Sep 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Quality SleepStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Principal investigator, Noam Alperin, University of Miami
- Investigators
- Noam Alperin, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583033
- Sponsor's protocol ID
- 20201031
- Status last verified
- Nov 2023
- First submitted
- 6 Oct 2020
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Stressors of Hippocampus and Alzheimer's Disease (AD) Related Brain Regions: Potential for Intervention
- ClinicalTrials.gov ID
- NCT04583033
- Acronym / sponsor ID
- 20201031
- Conditions
- Poor Quality Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 12 Oct 2020 (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.
The purpose of this study is to slow down the aging of the participant's brain by improving sleep quality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) Group | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT)Participants will receive CBT intervention bi-weekly for total of six (6) sessions. |
| Control Group | No intervention | –Participants will not receive any intervention as part of the study. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking healthy subjects age 55 years and older capable and willing to consent to participate in the study. In addition, subject should be cognitively normal and have well documented sleep issues that results with poor sleep quality based on self-reported assessment.
Key exclusion criteria (6 listed)
- pregnant women
- cognitively impaired subjects not able to provide consent
- prisoners
- Subjects 55 years of age and older that meet criteria for mild cognitive impairment.
- Subjects with any neurological disorder.
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 |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)Treatment components include stimulus control, sleep restriction therapy, relaxation, and cognitive therapy. Each session will last approximately one hour and will be provided on line. | Behavioural | Cognitive Behavioral Therapy (CBT) Group |
Primary outcome
Rate of brain tissue volume loss in specific brain regions
Time frame: Year 2
As evaluated from the Magnetic Resonance Imaging (MRI) Brain scan
1 secondary outcome
Cognitive Performance
Time frame: Year 2
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 1 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Noam Alperin principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) in people with Poor Quality Sleep, run by University of Miami at 1 site in United States.
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 1 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 1 Dec 2023. 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.
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?
Rate of brain tissue volume loss in specific brain regions (time frame: Year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2023.