CClinicalTrials.gg
Not yet recruitingNCT07518368SOARPilotUpdated Apr 8, 2026

Sleep Optimization to Aid in Recovery Digital Program

An interventional study of SOAR in Sleep Health, Binge Eating and Disordered Eating, sponsored by University of Nevada, Las Vegas. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by University of Nevada, Las Vegas · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Sleep Health
  • Binge Eating
  • Disordered Eating
  • Sleep Disturbances

Keywords

  • Eating disorders
  • Disordered eating
  • Binge eating
  • Sleep health
  • Sleep disturbances
  • waitlist
  • eating disorder treatment
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • None
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
154 participants (estimated)

Study arms

  • Experimental
    SOAR Intervention

    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.

    Behavioral: SOAR

  • No intervention
    Control Group

    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.

Interventions

  • BehavioralSOAR

    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.

05

What researchers measure

Primary outcomes

  1. PROMIS Sleep Disturbance

    Scores range from 8 to 40 with higher scores indicating greater sleep disturbance.

    Time frame: Baseline and one-month follow-up

  2. PROMIS Sleep Impairment

    Scores range from 8 to 40 with higher scores indicating greater impairment from sleep problems.

    Time frame: Baseline and one-month follow-up

Secondary outcomes

  1. Acceptability of Intervention Measure (AIM)

    Scores range from 1 to 5 with higher scores indicating greater acceptability of the intervention.

    Time frame: Within 24 hours post-intervention

  2. Intervention Appropriateness Measure (IAM)

    Scores range from 1 to 5 with higher scores indicating greater appropriateness of the intervention.

    Time frame: Within 24 hours post-intervention

  3. Feasibility of Intervention Measure (FIM)

    Scores range from 1 to 5 with higher scores indicating greater feasibility of the intervention.

    Time frame: Within 24 hours post-intervention

  4. System Usability Scale (SUS)

    Scores range from 0 to 100 with higher scores indicating greater usability of the intervention.

    Time frame: Within 24 hours post-intervention

  5. Sleep Hygiene Index

    Scores range from 13-65 with higher global scores indicative of more maladaptive sleep hygiene practices.

    Time frame: Baseline and one-month follow-up

Other outcomes

  1. Sleep Health (RU-SATED)

    Scores range from 0 to 14 with higher scores indicating better sleep health

    Time frame: Baseline and one-month follow-up

  2. Eating Disorder-15

    Scores for the two factors (Weight \& Shape Concerns and Eating Concerns) and the total score are presented as an average score (between 0 to 6) with a higher score indicating more eating-disordered cognitions and behaviors.

    Time frame: Baseline and one-month follow-up

  3. Generalized Anxiety Disorder-7

    Scores range from 0 to 21 with higher scores indicate greater generalized anxiety disorder pathology.

    Time frame: Baseline and one-month follow-up

  4. Patient Health Questionnaire-8

    Scores range from 0 to 24 with higher scores indicating greater depressive pathology. The suicidality question from the PHQ-9 will not be administered.

    Time frame: Baseline and one-month follow-up

  5. Self-Efficacy Scale

    Scores range from 10 to 40 with higher scores indicating greater self-efficacy.

    Time frame: Baseline and one-month follow-up

  6. Clinical Impairment Asssessment

    Scores range from 0 to 48 with higher scores indicating greater impairment from eating disorder symptoms.

    Time frame: Baseline and one-month follow-up

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07518368
Lead sponsor
University of Nevada, Las Vegas
Responsible party
Sponsor
First posted
Apr 8, 2026
Start date
May 2026 (estimated)
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Apr 8, 2026

Study contacts

Rosha Feizi Lighvan, B.A.
Contact
crest@unlv.edu
702-895-2099
Kara Christensen Pacella, Ph.D.
principal investigator · University of Nevada, Las Vegas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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