SleepSiESTa 2NCT06336590
Student Exercise and Sleep Timing Study - Part 2
A study testing Morning Exercise in people with Sleep and Mood, run by Rutgers, The State University of New Jersey at 6 sites in United States.
Trial summary
The purpose of this study is to examine the effects of a morning exercise intervention on sleep (quality and duration), mood (positive affect, anxiety, depression, anger), stress and productivity among undergraduate students (18-23 years) evening-exercisers with poor self-reported sleep quality. Aim 1. Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- What is being tested?
- Morning Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 6 sitesUnited States
- Study dates
- 21 Oct 2024to 16 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy undergraduates (18-23 years)
- Frequent evening exercisers (6pm-11pm, 3+ times per week)
- Poor self-reported sleep quality
- Must be willing to wear wrist actigraph 24/7 except when showering/bathing
Who cannot join
- Sleep/circadian rhythm disorders
- Medications for sleep
- Inability to change schedule to exercise in AM
- Inability to maintain exercise frequency over next 4 weeks
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
College Avenue Gym
New Brunswick, New Jersey, 08901
Assistant Director of Operations, 848-932-8063, samantha.plum@rutgers.edu
- Recruiting
Cook/Douglass Rec Center
New Brunswick, New Jersey, 08901
Assistant Director of Operations, 848-932-8063, samantha.plum@rutgers.edu
- Recruiting
Rutgers Fitness Center
New Brunswick, New Jersey, 08901
Assistant Director of Operations, 848-932-8063, samantha.plum@rutgers.edu
- Recruiting
Rutgers Sleep Lab
New Brunswick, New Jersey, 08901
Research Coordinator, 6103041363, cc2250@kines.rutgers.edu
- Recruiting
Livingston Rec Center
Piscataway, New Jersey, 08854
Assistant Director of Operations, 848-932-8063, samantha.plum@rutgers.edu
- Recruiting
Werblin Rec Center
Piscataway, New Jersey, 08854
Assistant Director of Operations, 848-932-8063, samantha.plum@rutgers.edu
About this study
The purpose of this study is to examine the effects of a morning exercise intervention on sleep (quality and duration), mood (positive affect, anxiety, depression, anger), stress and productivity among undergraduate students (18-23 years) evening-exercisers with poor self-reported sleep quality.
Aim 1. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved sleep quality (increased efficiency, decreased fragmentation) and increased sleep duration.
Read more
Aim 2. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved mood (increased positive affect, decreased depression, anxiety and anger).
Aim 3. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit decreased stress and increased productivity.
- Being tested
- Morning Exercise
- Keywords
- Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning ExerciseBehavioural
Exercise is changed from normal (6pm-11pm) exercise to morning (6am-11am) exercise.
| Study group | Role | What they receive |
|---|---|---|
| Normal Exercise | No intervention | This arm has no intervention. Participants will continue to exercise at their normal evening time (6pm-11pm). |
| Morning Exercise | Experimental | Participants will change their exercise times to the morning (6am-11am). Receives: Behavioral: Morning Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Determine if, compared to a control condition (maintaining usual schedule), shifting exercise from evening to morning improves sleep (quality and duration). Sleep quality includes variables such as the actigraph measured sleep period, total sleep time, sleep efficiency, and wake after sleep onset. Sleep quality and duration will be measured using wrist actigraphy, specifically the Phillips Actiwatch Spectrum Plus devices. The Epworth Sleepiness Scale will also be utilized to measure sleep quality, where scores range from 0-24 and higher scores signify more exhaustion and poorer sleep quality.
Measured: 2 weeks
Secondary outcomes (3)
Mood
Determine if, compared to a control condition (maintaining usual schedule), shifting exercise from evening to morning improves mood (positive affect, depression, anxiety, anger). This will be measure using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form questionnaires for anger, anxiety, depression, and positive affect. Each subsection has a separate score, with higher scores indicating higher levels of anger (scores range from 5-25), anxiety (scores range from 8-40), depression (scores range from 8-40), or positive affect (scores range from 15-75) for each subsection.
Measured: 2 weeks
Stress
Determine if, compared to a control condition (maintaining usual schedule), shifting exercise from evening to morning improves stress levels. This will be measured using the Perceived Stress Scale published in the Journal of Health and Social Behavior in 1983. Higher scores indicate higher stress levels with scores ranging from 0 to 56.
Measured: 2 weeks
Productivity
Determine if, compared to a control condition (maintaining usual schedule), shifting exercise from evening to morning increases productivity. This will be measured using a 5-item questionnaire with a 4-answer scale of poor to excellent (1-4, respectively). The items ask about overall productivity, class attendance, time management, memory, and ability to maintain attention. Higher scores indicate greater productivity with scores ranging from 5 to 20.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start21 Oct 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea M. Spaeth, PhD, Rutgers, The State University of New Jersey
- Investigators
- Andrea Spaeth, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336590
- Sponsor's protocol ID
- Pro2024000249
- Acronym
- SiESTa 2
- Status last verified
- Nov 2024
- First submitted
- 29 Feb 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The only IDP sharing that may occur is to other vetted researchers, it will not be made available to all researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Student Exercise and Sleep Timing Study - Part 2
- ClinicalTrials.gov ID
- NCT06336590
- Acronym / sponsor ID
- SiESTa 2 / Pro2024000249
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 29 Mar 2024 (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 examine the effects of a morning exercise intervention on sleep (quality and duration), mood (positive affect, anxiety, depression, anger), stress and productivity among undergraduate students (18-23 years) evening-exercisers with poor self-reported sleep quality.
Aim 1. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved sleep quality (increased efficiency, decreased fragmentation) and increased sleep duration.
Aim 2. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved mood (increased positive affect, decreased depression, anxiety and anger).
Aim 3. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit decreased stress and increased productivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Exercise | No intervention | –This arm has no intervention. Participants will continue to exercise at their normal evening time (6pm-11pm). |
| Morning Exercise | Experimental | Behavioral: Morning ExerciseParticipants will change their exercise times to the morning (6am-11am). |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy undergraduates (18-23 years)
- Frequent evening exercisers (6pm-11pm, 3+ times per week)
- Poor self-reported sleep quality
- Must be willing to wear wrist actigraph 24/7 except when showering/bathing
Key exclusion criteria (4 listed)
- Sleep/circadian rhythm disorders
- Medications for sleep
- Inability to change schedule to exercise in AM
- Inability to maintain exercise frequency over next 4 weeks
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 |
|---|---|---|
| Morning ExerciseExercise is changed from normal (6pm-11pm) exercise to morning (6am-11am) exercise. | Behavioural | Morning Exercise |
Primary outcome
Sleep Quality
Time frame: 2 weeks
Determine if, compared to a control condition (maintaining usual schedule), shifting exercise from evening to morning improves sleep (quality and duration). Sleep quality includes variables such as the actigraph measured sleep period, total sleep time, sleep efficiency, and wake after sleep onset. Sleep quality and duration will be measured using wrist actigraphy, specifically the Phillips Actiwatch Spectrum Plus devices. The Epworth Sleepiness Scale will also be utilized to measure sleep quality, where scores range from 0-24 and higher scores signify more exhaustion and poorer sleep quality.
3 secondary outcomes
Mood
Time frame: 2 weeks
Stress
Time frame: 2 weeks
Productivity
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Yes. The only IDP sharing that may occur is to other vetted researchers, it will not be made available to all researchers.
Related trials for Sleep
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Not yet recruitingObservational study
Stress, Coping, and Sleep Health Study
Sleep
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.
Andrea Spaeth, PhD principal investigator
Rutgers, The State University of New Jersey
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning Exercise in people with Sleep and Mood, run by Rutgers, The State University of New Jersey at 6 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator (610-304-1363, cc2250@kines.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: 2 weeks). 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 21 Nov 2024.