Sleep HealthSOARPilotNCT07518368
Sleep Optimization to Aid in Recovery Digital Program
A study testing SOAR in people with Sleep Health and Binge Eating, run by University of Nevada, Las Vegas.
Trial summary
The purpose of this pilot study is to evaluate the usability and feasibility of SOAR (Sleep Optimization to Aid Recovery), a brief and self-guided digital program designed to share evidence-based sleep hygiene information with individuals seeking treatment for an eating disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Health, Binge Eating, Disordered Eating
- What is being tested?
- SOAR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Mar 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older,
- Initiating treatment for an eating disorder (e.g., currently on a waitlist for eating disorder treatment, scheduled to start treatment, completed an intake, or started treatment within the past two weeks for an eating disorder),
- Able to access the internet
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this pilot study is to evaluate the usability and feasibility of SOAR (Sleep Optimization to Aid Recovery), a brief and self-guided digital program designed to share evidence-based sleep hygiene information with individuals seeking treatment for an eating disorder. The SOAR program delivers well-established recommendations promoted by the National Sleep Foundation and other professional sleep health organizations. The purpose of this study is not to test a new treatment or intervention per se, but rather to examine how effectively this existing information can be delivered through a digital platform to people preparing for or engaged in eating disorder treatment. By providing these evidence-based strategies in a user-friendly and accessible format, SOAR aims to support healthy sleep habits that may enhance overall well-being and facilitate recovery.
The investigators will compare SOAR against a control condition, which would be no intervention (treatment-as-usual). Participants randomized to the control will receive access to SOAR after the follow-up period has ended, if they wish to use it.
- Conditions
- Sleep Health, Binge Eating, Disordered Eating, Sleep Disturbances
- Being tested
- SOAR
- Keywords
- Eating disorders, Disordered eating, Binge eating, Sleep health, Sleep disturbances, waitlist, eating disorder treatment
- Medical subject headings
- Bulimia, Parasomnias, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOARBehavioural
SOAR is administered using the REDCap platform. It consists of a series of videos about the science behind the link between eating disorders and sleep and best practices and tips for sleep health recommended by leading sleep health organizations. SOAR includes sleep hygiene information, videos on stimulus control (a best practices intervention for insomnia), and instructions for setting a regular sleep/wake time. At the end of the program, users will create a sleep action plan using the information they learned from SOAR.
| Study group | Role | What they receive |
|---|---|---|
| SOAR Intervention | Experimental | The SOAR program is designed to help improve sleep health for people beginning eating disorder treatment. The packaging of the SOAR intervention (e.g., videos) and the targeting of these materials to an eating disorder treatment context represent the novel experimental contributions of this program. Receives: Behavioral: SOAR |
| Control Group | No intervention | The current standard of care is no intervention. The no intervention condition thus is treatment-as-usual. Participants will receive the option to access the active intervention at the conclusion of their study participation. These participants will complete the baseline session and the follow-up survey only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Sleep Disturbance
Scores range from 8 to 40 with higher scores indicating greater sleep disturbance.
Measured: Baseline and one-month follow-up
PROMIS Sleep Impairment
Scores range from 8 to 40 with higher scores indicating greater impairment from sleep problems.
Measured: Baseline and one-month follow-up
Secondary outcomes (5)
Acceptability of Intervention Measure (AIM)
Scores range from 1 to 5 with higher scores indicating greater acceptability of the intervention.
Measured: Within 24 hours post-intervention
Intervention Appropriateness Measure (IAM)
Scores range from 1 to 5 with higher scores indicating greater appropriateness of the intervention.
Measured: Within 24 hours post-intervention
Feasibility of Intervention Measure (FIM)
Scores range from 1 to 5 with higher scores indicating greater feasibility of the intervention.
Measured: Within 24 hours post-intervention
System Usability Scale (SUS)
Scores range from 0 to 100 with higher scores indicating greater usability of the intervention.
Measured: Within 24 hours post-intervention
Sleep Hygiene Index
Scores range from 13-65 with higher global scores indicative of more maladaptive sleep hygiene practices.
Measured: Baseline and one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep HealthStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kara Christensen Pacella, Ph.D., Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518368
- Sponsor's protocol ID
- UNLV-2025-634
- Acronym
- SOARPilot
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial will be included; however, any personal information that could identify participants will be removed or recoded prior to sharing.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Optimization to Aid in Recovery Digital Program
- ClinicalTrials.gov ID
- NCT07518368
- Acronym / sponsor ID
- SOARPilot / UNLV-2025-634
- Conditions
- Sleep Health, Binge Eating, Disordered Eating, Sleep Disturbances
- Keywords
- Eating disorders, Disordered eating, Binge eating, Sleep health, Sleep disturbances, waitlist, eating disorder treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 8 Apr 2026 (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 pilot study is to evaluate the usability and feasibility of SOAR (Sleep Optimization to Aid Recovery), a brief and self-guided digital program designed to share evidence-based sleep hygiene information with individuals seeking treatment for an eating disorder. The SOAR program delivers well-established recommendations promoted by the National Sleep Foundation and other professional sleep health organizations. The purpose of this study is not to test a new treatment or intervention per se, but rather to examine how effectively this existing information can be delivered through a digital platform to people preparing for or engaged in eating disorder treatment. By providing these evidence-based strategies in a user-friendly and accessible format, SOAR aims to support healthy sleep habits that may enhance overall well-being and facilitate recovery.
The investigators will compare SOAR against a control condition, which would be no intervention (treatment-as-usual). Participants randomized to the control will receive access to SOAR after the follow-up period has ended, if they wish to use it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOAR Intervention | Experimental | Behavioral: SOARThe SOAR program is designed to help improve sleep health for people beginning eating disorder treatment. The packaging of the SOAR intervention (e.g., videos) and the targeting of these materials to an eating disorder treatment context represent the novel experimental contributions of this program. |
| Control Group | No intervention | –The current standard of care is no intervention. The no intervention condition thus is treatment-as-usual. Participants will receive the option to access the active intervention at the conclusion of their study participation. These participants will complete the baseline session and the follow-up survey only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older,
- Initiating treatment for an eating disorder (e.g., currently on a waitlist for eating disorder treatment, scheduled to start treatment, completed an intake, or started treatment within the past two weeks for an eating disorder),
- Able to access the internet
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| SOARSOAR is administered using the REDCap platform. It consists of a series of videos about the science behind the link between eating disorders and sleep and best practices and tips for sleep health recommended by leading sleep health organizations. SOAR includes sleep hygiene information, videos on stimulus control (a best practices intervention for insomnia), and instructions for setting a regular sleep/wake time. At the end of the program, users will create a sleep action plan using the information they learned from SOAR. | Behavioural | SOAR Intervention |
Primary outcome
PROMIS Sleep Disturbance
Time frame: Baseline and one-month follow-up
Scores range from 8 to 40 with higher scores indicating greater sleep disturbance.
PROMIS Sleep Impairment
Time frame: Baseline and one-month follow-up
Scores range from 8 to 40 with higher scores indicating greater impairment from sleep problems.
5 secondary outcomes
Acceptability of Intervention Measure (AIM)
Time frame: Within 24 hours post-intervention
Intervention Appropriateness Measure (IAM)
Time frame: Within 24 hours post-intervention
Feasibility of Intervention Measure (FIM)
Time frame: Within 24 hours post-intervention
System Usability Scale (SUS)
Time frame: Within 24 hours post-intervention
Sleep Hygiene Index
Time frame: Baseline and one-month follow-up
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 8 Apr 2026.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial will be included; however, any personal information that could identify participants will be removed or recoded prior to sharing.
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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.
Kara Christensen Pacella, Ph.D. principal investigator
University of Nevada, Las Vegas
Questions about this trial
What is this clinical trial studying?
A study testing SOAR in people with Sleep Health and Binge Eating, run by University of Nevada, Las Vegas.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Rosha Feizi Lighvan, B.A. (702-895-2099, crest@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Sleep Disturbance (time frame: Baseline and one-month follow-up). The study lists 2 primary outcomes in all. 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 8 Apr 2026.