Sleep InsufficiencyPhase 2NCT05789212

A Personalized Mind-Body Intervention (MBI) for Improving Sleep Among Women Working in Healthcare

A Phase 2 study testing Personalized Trial ABCCBA and Personalized Trial CBAABC in people with Sleep Insufficiency, run by Northwell Health 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

Who is it for?: Ages 40 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Sleep Insufficiency
What is being tested?: Personalized Trial ABCCBA and Personalized Trial CBAABC
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: 22 May 2023to 3 Jan 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Women (biological sex at birth)
Age 40-60 years old
Northwell employee/affiliate
Self-reported history of short sleep duration (<7h per 24-h period) for at least 3 months
After 2-week run-in, Fitbit-verified short sleep duration and ≥80% adherence of Fitbit wear and survey submission
Self-report of perceived stress ≥18 using the Perceived Stress Scale (PSS)
Access to and capable of using a smartphone
Can regularly wear a Fitbit device

Who cannot join

Men (biological sex at birth)
Age < 40 or >60 years old
Women who are pregnant
Not a Northwell employee/affiliate
No history of short sleep duration or non-adherent to the Fitbit wear and survey submission
Self-report of perceived stress <18 using the Perceived Stress Scale (PSS)

Show all 11Show fewer

Does not own or cannot regularly access a smartphone
Cannot regularly wear a Fitbit device
Unable to complete the study due to cognitive impairment, severe medical or mental illness, or active/prior substance abuse
Planned surgeries 6 months from study start date
Participants who have been previously told by a doctor/clinician they have mobility limiting health conditions and/or to not engage in walking 30 minutes, three times per week or yoga

Trial locations and contacts

1 site in 1 country.

United States1 site

Institute of Health System Science
New York, New York, 10022

Other trials in United States

About this study

Official title: A Personalized (N-of-1) Trial for Testing the Effect of a Mind-Body Intervention (MBI) on Sleep Duration and Quality in Middle-Aged Women Working in Healthcare

The goal of this pilot study is to determine if a personalized trial testing a Mind-Body Intervention (MBI) can produce a meaningful increase in the average daily sleep duration among women 40-60 years of age working in healthcare. A total of 60 eligible participants will be randomized to one of two possible orders of treatment exposure comprised of three components: mindfulness, yoga, and guided walking, each assigned in 2-week block sequences for a total period of 12 weeks. The study will include a 2-week baseline period during which their baseline sleep duration and adherence to the Fitbit wear and survey submission will be assessed. Following the 2-week run-in period, participants deemed eligible and achieved at least 80% adherence of Fitbit wear and survey submission will be randomized to one of the two intervention arms. Exploratory aims include assessments of sleep quality, physiological factors and their direct and indirect relationships with participants' perceived stress, anxiety, and depression.

Read the detailed description

The goal of this pilot study is to determine if a personalized trial (N-of-1) employing a Mind-Body Intervention (MBI) can produce a meaningful increase in sleep duration among women 40-60 years of age working at Northwell Health. A total of 60 women with a history of short sleep duration (defined as an average <7h per 24-h period for at least three months) will be enrolled over a period of two years. Participants will complete a 2-week run-in period with no intervention, during which their baseline sleep duration and adherence to the Fitbit wear and survey submission will be assessed. Adherence to Fitbit wear will be defined as recorded activity of greater than 12 hours a day, and recorded sleeping activity greater than 180 minutes in total. Survey adherence will be defined as submission of a given survey. Participants who achieve at least 80% adherence of Fitbit wear and survey submission during baseline period will be randomized to Arm 1 (N=30) or Arm 2 (N=30). Each arm will receive a personalized intervention comprised of three components: mindfulness, yoga and guided walking assigned in 2-week block sequences for a total period of 12 weeks. During each 2-week block, participants will be prompted to complete 3 x 30-minute intervention sessions weekly. 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. Changes in average daily sleep duration will be calculated for each participant based on daily measurements between the run-in and each treatment period. The Fitbit devices will also record sleep quality components (sleep onset, sleep staging, and overall sleep score) and physiological factors (breathing/resting heart rate, heart rate variability (HRV) and activity). We will also examine the direct and indirect relationships between perceived stress, anxiety and depression, and sleep quality assessed pre, during (bi-weekly), and post MBI. Enrollment will continue until up to 60 participants have been randomized. Following the intervention, all participants will be assessed over a 2-week follow-up period to allow for a personalized report of their observed data to be generated.

Conditions: Sleep Insufficiency
Being tested: Personalized Trial ABCCBA, Personalized Trial CBAABC
Keywords: Sleep duration, Sleep quality, Anxiety, Depression
Medical subject headings: Sleep Deprivation, Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Depression

What participants receive

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

Personalized Trial ABCCBABehavioural
Participants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (ABCCBA), where A-mindfulness, B-yoga, and C-guided walking.
Personalized Trial CBAABCBehavioural
Participants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (CBAABC), where A-mindfulness, B-yoga, and C-guided walking.

Study groups in NCT05789212
Study group	Role	What they receive
Personalized Trial ABCCBA	Experimental	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. Receives: Behavioral: Personalized Trial ABCCBA
Personalized Trial CBAABC	Experimental	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. Receives: Behavioral: Personalized Trial CBAABC

What is being measured

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

Mean Within-Subject Difference in Daily Sleep Duration
The effect of the personalized MBI intervention on individual's sleep duration will be assessed in each arm separately. Participants' daily sleep duration will be measured objectively using Fitbit devices and by self-reported questionnaires. Individual changes in the average daily sleep durations between the run-in and each treatment period will be reported using means and 95% CIs. Bland-Altman plots will be constructed to visualize agreement between Fitbit reported and self-reported sleep duration. The effects of treatment on sleep duration will be assessed using GEE with an unstructured variance-covariance matrix for measures on the same day to that night's sleep. This model accounts for possible autocorrelation and linear trends between sleep duration across time.
A change between time points is reported (e.g., baseline (2 weeks) and 2 weeks for each intervention period (4 weeks per intervention)) as a value for each intervention period minus value at baseline.
Measured: Baseline (2 weeks) and 2 weeks for each intervention period (4 weeks total for each intervention)

Timeline

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

22 May 20233 Jan 2025

First posted29 Mar 2023
Study start22 May 2023
Primary completion15 Dec 2024
Study completion3 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sleep InsufficiencyStudies 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 2
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Model description: Mixed between and within (Crossover) participant assignment. The study uses a between participant randomization; each of the two arms have a multiple crossover design (with different intervention orders to the crossover).
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05789212
Sponsor's protocol ID: 22-0770
Other IDs: P30AG063786-01
Status last verified: Jan 2026
First submitted: 13 Mar 2023
Last updated: 2 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary.

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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Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Personalized (N-of-1) Trial for Testing the Effect of a Mind-Body Intervention (MBI) on Sleep Duration and Quality in Middle-Aged Women Working in Healthcare
ClinicalTrials.gov ID: NCT05789212
Acronym / sponsor ID: 22-0770
Conditions: Sleep Insufficiency
Keywords: Sleep duration, Sleep quality, Anxiety, Depression
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Northwell HealthUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 22 May 2023 (actual)
Primary completion: 15 Dec 2024 (actual)
Study completion: 3 Jan 2025 (actual)
First posted: 29 Mar 2023 (actual)
Results: Posted 2 Feb 2026

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: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Mixed between and within (Crossover) participant assignment. The study uses a between participant randomization; each of the two arms have a multiple crossover design (with different intervention orders to the crossover).

Arm	Type	Receives
Personalized Trial ABCCBA	Experimental	Behavioral: Personalized Trial ABCCBAParticipants 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.
Personalized Trial CBAABC	Experimental	Behavioral: Personalized Trial CBAABCParticipants 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.

Who may qualify

Ages: 40 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Women (biological sex at birth)
Age 40-60 years old
Northwell employee/affiliate
Self-reported history of short sleep duration (<7h per 24-h period) for at least 3 months
After 2-week run-in, Fitbit-verified short sleep duration and ≥80% adherence of Fitbit wear and survey submission

Key exclusion criteria (11 listed)

Men (biological sex at birth)
Age < 40 or >60 years old
Women who are pregnant
Not a Northwell employee/affiliate
No history of short sleep duration or non-adherent to the Fitbit wear and survey submission

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
Personalized Trial ABCCBAParticipants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (ABCCBA), where A-mindfulness, B-yoga, and C-guided walking.	Behavioural	Personalized Trial ABCCBA
Personalized Trial CBAABCParticipants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (CBAABC), where A-mindfulness, B-yoga, and C-guided walking.	Behavioural	Personalized Trial CBAABC

Primary outcome

Mean Within-Subject Difference in Daily Sleep Duration
Time frame: Baseline (2 weeks) and 2 weeks for each intervention period (4 weeks total for each intervention)
The effect of the personalized MBI intervention on individual's sleep duration will be assessed in each arm separately. Participants' daily sleep duration will be measured objectively using Fitbit devices and by self-reported questionnaires. Individual changes in the average daily sleep durations between the run-in and each treatment period will be reported using means and 95% CIs. Bland-Altman plots will be constructed to visualize agreement between Fitbit reported and self-reported sleep duration. The effects of treatment on sleep duration will be assessed using GEE with an unstructured variance-covariance matrix for measures on the same day to that night's sleep. This model accounts for possible autocorrelation and linear trends between sleep duration across time. A change between time points is reported (e.g., baseline (2 weeks) and 2 weeks for each intervention period (4 weeks per intervention)) as a value for each intervention period minus value at baseline.

Results and safety

Results posted to the registry on 2 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Personalized Trial Group 1 (ABCCBA)	30	29
Personalized Trial Group 2 (CBAABC)	30	27

Primary outcome: Mean Within-Subject Difference in Daily Sleep Duration

Time frame: Baseline (2 weeks) and 2 weeks for each intervention period (4 weeks total for each intervention). Mean (95% Confidence Interval). Unit: minutes per day

Measure	Personalized Trial Group 1 (ABCCBA) n = 30	Personalized Trial Group 2 (CBAABC) n = 30	Overall (All Participants) n = 60
Guided Walking (C)	0.10 (-12.6 to 12.8)	3.45 (-12.0 to 18.9)	1.74 (-7.04 to 10.5)
Mindfulness Meditation (A)	0.43 (-11.9 to 12.8)	1.66 (-14.1 to 17.4)	0.81 (-7.94 to 9.57)
Yoga (B)	-2.89 (-15.2 to 9.41)	5.94 (-9.78 to 21.7)	1.27 (-7.43 to 9.97)

Adverse events

Time frame: Non-systematic adverse event data was collected over the course of the 16-week trial: 2-week baseline period, 12-week intervention, and 2-week follow-up period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindfulness Meditation (A)	0 of 60 (0%)	3 of 60 (5%)	4 of 60
Yoga (B)	0 of 60 (0%)	0 of 60 (0%)	1 of 60
Walking (C)	0 of 60 (0%)	2 of 60 (3.3%)	2 of 60
No Intervention (Baseline)	0 of 60 (0%)	1 of 60 (1.7%)	5 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary.

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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.

Karina Davidson, PhD, MASc principal investigator

Northwell Health

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Personalized Trial ABCCBA and Personalized Trial CBAABC in people with Sleep Insufficiency, run by Northwell Health 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 8 inclusion and 11 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 2 Feb 2026. 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 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.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Within-Subject Difference in Daily Sleep Duration (time frame: Baseline (2 weeks) and 2 weeks for each intervention period (4 weeks total for each intervention)). 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 NCT05789212.

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 2 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.