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Sleep Health Education for Insomnia (SWELL24 Trial)
N/A
Recruiting
Led By Jaime M Hughes, PhD, MPH, MSW
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 2
Awards & highlights
SWELL24 Trial Summary
This trial aims to create a plan to help elderly people get better sleep, and see if it works and is accepted.
Who is the study for?
The SWELL24 trial is for adults over 65 who have insomnia, can follow instructions, and have had a primary care visit at Wake Forest Baptist Health in the past year. They should be physically inactive but able to walk safely with or without help. Those with serious medical conditions, untreated sleep disorders like sleep apnea or restless leg syndrome, substance abuse issues, or living in institutional care cannot join.Check my eligibility
What is being tested?
This study tests an intervention that includes education and coaching to promote healthy sleep-wake behaviors among older adults. It aims to establish effective daytime activities as part of a comprehensive approach to improve their overall sleep quality.See study design
What are the potential side effects?
Since this trial involves behavioral interventions such as education and coaching rather than medication, side effects are not expected in the traditional sense. However, participants may experience changes in daily routines which could temporarily affect their sleeping patterns.
SWELL24 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sleep efficiency
Secondary outcome measures
Insomnia severity scores
daytime consequences
total daytime activity
SWELL24 Trial Design
1Treatment groups
Experimental Treatment
Group I: education and coaching on developing healthy nighttime sleep and daytime activity behaviorsExperimental Treatment1 Intervention
The intervention includes a four-session, in-person program delivered by a Master's-level provider. Each individual session will be approximately 30-45 minutes in length. Each session will include education and coaching on developing healthy nighttime sleep and daytime activity behaviors.
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Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,017,051 Total Patients Enrolled
10 Trials studying Insomnia
1,775 Patients Enrolled for Insomnia
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,225 Total Patients Enrolled
4 Trials studying Insomnia
376 Patients Enrolled for Insomnia
Jaime M Hughes, PhD, MPH, MSWPrincipal InvestigatorWake Forest University Health Sciences
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can walk safely on my own or with help.I have not been treated for any sleep disorders like sleep apnea or restless leg syndrome.I am 65 years old or older.I can understand and follow the study's instructions.My medical records show I cannot make my own health decisions.I have been diagnosed with Insomnia Disorder.I do not have any severe health or mental conditions that would stop me from joining a study.
Research Study Groups:
This trial has the following groups:- Group 1: education and coaching on developing healthy nighttime sleep and daytime activity behaviors
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment continue to accept participants?
"Clinicaltrials.gov confirms that this clinical trial, first posted on June 1st 2023, is not currently enrolling patients at this time. However, there are 203 other studies actively seeking participants as of April 27th 2023."
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