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Mind-Body Intervention for Sleep Deprivation
Phase 2
Recruiting
Led By Karina Davidson, PhD, MASc
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women (biological sex at birth) aged 40-60 years old
Access to and capable of using a smartphone
Must not have
Unable to complete the study due to cognitive impairment, severe medical or mental illness, or active/prior substance abuse
Men (biological sex at birth)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13-16 weeks
Awards & highlights
Summary
This trial will test if a Mind-Body Intervention can help women 40-60 in healthcare sleep more. It'll include mindfulness, yoga, and walking over 12 weeks, plus assessments of sleep quality, stress, anxiety, and depression.
Who is the study for?
This trial is for women aged 40-60 working in healthcare with a self-reported history of sleeping less than 7 hours per night for at least three months. They must be experiencing stress and able to use a smartphone and Fitbit regularly. Exclusions include severe illness, substance abuse, inability to walk or do yoga as advised by a doctor, pregnancy, men, those outside the age range, and non-Northwell employees.
What is being tested?
The study tests if Mind-Body Interventions (MBI) like mindfulness, yoga, and guided walking can increase sleep duration over 12 weeks. Participants will first have their baseline sleep measured for two weeks using Fitbit; those adhering well are then randomly assigned one of two sequences of the MBI components.
What are the potential side effects?
Since this trial involves non-invasive practices such as mindfulness exercises, yoga sessions, and guided walks designed to improve sleep patterns among participants without using medication or medical procedures there are no significant side effects expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged between 40 and 60.
Select...
I can use a smartphone.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe mental illness, cognitive issues, or a history of substance abuse that would prevent me from completing the study.
Select...
I am biologically male.
Select...
I am younger than 40 or older than 60 years old.
Select...
I am currently pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13-16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13-16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Within-Subject Difference in Daily Sleep Duration
Other study objectives
Mean Within-Subject Difference in Anxiety and Depression Scores
Mean Within-Subject Difference in Daily Number of Steps
Mean Within-Subject Difference in Daily Resting Heart Rate
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Personalized Trial CBAABCExperimental Treatment1 Intervention
Participants in Arm 2 will receive a Personalized Trial comprised of three components delivered in a CBAABC sequence over a total period of 12 weeks, where A-mindfulness, B-yoga, and C-guided walking. Participants in this arm will be prompted to complete 3 x 30-minute intervention sessions weekly during applicable treatment weeks. Interventions will be delivered by a virtual link to online videos recorded by an experienced wellness provider. Participants will be limited to three views of the study-provided intervention content each week.
Group II: Personalized Trial ABCCBAExperimental Treatment1 Intervention
Participants in Arm 1 will receive a Personalized Trial comprised of three components delivered in a ABCCBA sequence over a total period of 12 weeks, where A-mindfulness, B-yoga, and C-guided walking. Participants in this arm will be prompted to complete 3 x 30-minute intervention sessions weekly during applicable treatment weeks. Interventions will be delivered by a virtual link to online videos recorded by an experienced wellness provider. Participants will be limited to three views of the study-provided intervention content each week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Personalized Trial ABCCBA
2022
Completed Phase 2
~220
Personalized Trial CBAABC
2022
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
473 Previous Clinical Trials
472,212 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,943 Total Patients Enrolled
5 Trials studying Sleep Deprivation
1,013 Patients Enrolled for Sleep Deprivation
Karina Davidson, PhD, MAScPrincipal InvestigatorNorthwell Health
6 Previous Clinical Trials
576 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- After a two-week trial period, you consistently have short sleep and wear the Fitbit regularly.I cannot wear a Fitbit regularly.I have no surgeries planned within 6 months from joining the study.You have not consistently slept very little or forgotten to wear the Fitbit and submit the surveys.You have indicated that your stress level is less than 20 on the Perceived Stress Scale.You usually sleep less than 7 hours per night for at least 3 months.I am a woman aged between 40 and 60.I do not have severe mental illness, cognitive issues, or a history of substance abuse that would prevent me from completing the study.You have been advised by a doctor not to walk for 30 minutes, three times a week, or do yoga.You feel a lot of stress, scoring 20 or higher on the Perceived Stress Scale.I can use a smartphone.I can wear a Fitbit regularly.I am biologically male.I am younger than 40 or older than 60 years old.I am currently pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Personalized Trial ABCCBA
- Group 2: Personalized Trial CBAABC
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.
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