NCT07638267

Brief Summary

The goal of this clinical trial is to learn if yoga works to improve sleep and heart health in adults with and without insomnia disorder. The main questions it aims to answer are:

  • Does the style of yoga impact participants heart health overnight?
  • Does the style of yoga improve participants sleep following a single session? Researchers will compare adults with insomnia disorder to adults with healthy sleep . Participants will:
  • Complete a moderate-intensity yoga practice, a low-intensity intensity yoga practice, and a quiet rest period while watching a nature documentary in the evening on three separate evenings
  • Participants will have their sleep and heart health measured using a watch and heart rate monitor overnight following each visit

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jun 2026Sep 2026

First Submitted

Initial submission to the registry

June 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 1, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

sleepinsomniayogaheart healthheart rate variabilityactigraphy

Outcome Measures

Primary Outcomes (1)

  • Change in nocturnal root mean square of successive difference between normal heartbeats (RMSSD) heart rate variability (HRV)

    Nocturnal root mean square of successive difference between normal heartbeats will be assessed immediately after each experimental session for 1 night; a higher value indicates better cardiovascular health

    Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.

Secondary Outcomes (12)

  • Change in sleep efficiency

    Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.

  • Change in total sleep time

    Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.

  • Change in wake after sleep onset

    Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.

  • Change in sleep quality

    The following morning after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate mornings.

  • Change in nocturnal heart rate

    Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.

  • +7 more secondary outcomes

Study Arms (3)

vinyasa yoga

EXPERIMENTAL

60 minute moderate-intensity yoga session

Behavioral: Vinyasa yoga

gentle yoga

EXPERIMENTAL

60 minute low-intensity yoga session

Behavioral: Gentle yoga

Control Condition

OTHER

60-minute non-active control condition

Other: Non-active control

Interventions

Gentle yogaBEHAVIORAL

Participants will follow a pre-recorded standardized sequence that includes a person demonstrating each sequence and provides verbal cues for the gentle yoga session. This sequence focuses primarily on seated and supine postures and is designed to be accessible, safe, and restorative. All poses are low-impact and supported using yoga blocks to promote comfort and reduce physical strain.

gentle yoga

The non-active control session, participants will complete a quiet rest period while watching a nature documentary. The film is educational in nature and has been carefully selected to avoid any graphic, distressing, offensive, or psychologically sensitive content. It is commercially available and rated G for general audiences. Participants will be asked to remain seated and refrain from the use of electronic devices. A staff member will remain present to ensure participants following procedures.

Control Condition
Vinyasa yogaBEHAVIORAL

Participants will follow a pre-recorded standardized sequence that includes a person demonstrating each sequence and provides verbal cues for the vinyasa yoga session. The 60-minute vinyasa yoga protocol incorporated standing, seated, and supine postures and included the following order of sequences: integration, sun salutations, crescent lunge series, balancing, standing, back bending, and restorative series.

vinyasa yoga

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults 18-40 years
  • Insufficiently inactive define by the L-CAT (responses below public health physical activity guidelines)
  • Physical activity is not contraindicated (i.e., no affirmative responses on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
  • Adults with diagnosed insomnia disorder and score ≥ 10 on the Insomnia Severity Index
  • Good sleeps a score \< 10 (no history of sleep disorder)
  • Basic understanding of yoga poses
  • Access to a smart device (such as a smartphone or tablet)

You may not qualify if:

  • Regular yoga practice (\> 60 minutes per week)
  • Any diagnosed medical condition requiring medical clearance determined 'Yes' response on questions pertaining to a present medical condition(s) via PAR-Q+. This includes, but is not limited to, uncontrolled cardiovascular, metabolic, respiratory, musculoskeletal, neurological, or mental health conditions; recent stroke or concussion; active cancer treatment; and any combination of medical conditions that pose a health risk without physician supervision. All "yes" responses on the PAR-Q+ will be evaluated, and individuals requiring clearance will not be eligible to participate.
  • Physical limitations and/or mobility restrictions (such as bone, joint, or soft tissue such as muscle, ligament, or tendon that could be made worse by becoming more physically active) via PAR-Q+
  • Untreated major psychiatric disorders (e.g. major depression, bipolar disorder, schizophrenia)
  • Elevated risk for sleep apnea (i.e., STOP-Bang score ≥ 5)
  • Any other sleep disorders other than insomnia (e.g., sleep apnea, restless legs syndrome, circadian rhythm disorder, etc.)
  • Current treatment for insomnia (e.g., hypnotic medications, cognitive behavioral therapy for insomnia, etc.)
  • Current medications that affect heart or blood pressure (i.e., anti-depressants, beta-blockers, etc.)
  • Current or planned pregnancy within the next 3 months
  • Overnight shift work defined as regularly working anytime between 00:00 and 6:00am

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 10, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Individual deidentified data that are relevant to the primary aims of the study will be provided to external investigators along with a relevant data dictionary.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 1 year following peer-reviewed publication of research questions outlined in grant and ending 5 years following publication of study results
Access Criteria
Data access will be provided to external researchers who provide a methodologically sound proposal for secondary data analysis that is approved by the investigators of the study. Proposals should be directed to the study PI.

Locations