Sleep Interventions for Sleep Disorders

Overseen By Jessica Badawi

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Intellectual disability, One-to-one supervision, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a sleep program can improve sleep and mental health for patients in psychiatric care. It compares two approaches: usual care with regular safety checks and a special sleep promotion method using tools like scented oil, earplugs, and an eye mask. The trial focuses on how these methods affect sleep, depression, anxiety, and suicide risk, as well as the ease of using these methods. Suitable participants are those admitted to a psychiatric hospital for suicidal thoughts or actions and who can communicate in English. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative approach.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that the Improving Sleep Program is likely to be safe for humans?

Research has shown that earplugs and eye masks can improve sleep by reducing disturbances. Hospitals have safely used these tools to help patients rest. No major safety issues have been reported with earplugs and eye masks, so they are generally considered safe for enhancing sleep. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Improving Sleep Program because it introduces a novel approach to treating sleep disorders. Unlike standard treatments such as cognitive behavioral therapy or medication, this experimental method combines scented oil, earplugs, and eye masks to enhance sleep quality. Additionally, it leverages video-based safety checks to monitor participants while they sleep, offering a non-invasive and potentially more comfortable experience. This combination of sensory aids and digital monitoring could offer a refreshing alternative for those struggling with traditional sleep interventions.

What evidence suggests that the Sleep Interventions for Sleep Disorders trial's treatments could be effective?

Research has shown that earplugs and eye masks can improve sleep quality by reducing disruptions and making sleep more restful. In hospitals, patients who used these tools reported better sleep. One study found that earplugs and eye masks enhanced sleep quality more than standard care. In this trial, participants in the "Sleep promotion" arm will use scented oil, earplugs, and eye masks, while those in the "Treatment as usual" arm will receive standard care. This evidence suggests that earplugs and eye masks could benefit those with sleep problems. ^{1 2 3 6 7}

Who Is on the Research Team?

Michelle Patriquin, PhD, ABPP

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals in a psychiatric hospital with suicidal thoughts or sleep disorders. Participants should be currently experiencing these issues and willing to try interventions like ear plugs, scented oils, eye masks, or video-based safety checks.

Inclusion Criteria

English speaking

Cognitive ability as tested by the Montreal Cognitive Assessment (MoCA) of > 23

Has sufficient communication and comprehension ability to consent to the study

Exclusion Criteria

Patients enrolled in the study with a patient admitted as their roommate who requires one-to-one supervision or Q15 checks-Patient will be unenrolled if a room change is not possible

I require close monitoring for safety due to risks of harm to myself or others.

I am able to understand and consent to my medical treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive sleep promotion interventions or treatment as usual during inpatient psychiatric treatment

2 weeks

Daily monitoring (in-person and video-based)

Follow-up

Participants are monitored for changes in sleep, depression, anxiety, and suicide risk after discharge

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Improving Sleep Program

Trial Overview The study tests if promoting better sleep can improve mental health compared to usual treatment. It involves using items like ear plugs and eye masks versus standard safety checks. The impact on depression, anxiety, suicide risk, readmission rates, and objective sleep quality will be measured.

How Is the Trial Designed?

Group I: Sleep promotion Experimental Treatment 5 Interventions

Scented Oil Ear Plugs Eye Mask Video based safety checks will be done as long as participant is asleep. In person safety check will be done once participant is awake

Group II: Treatment as usual Active Control 1 Intervention

Only in person safety check will be conducted

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8678458/

The Efficacy of Eye Masks and Earplugs Interventions for ... The results of the present study suggest that the use of earplugs or eye masks, separately or combined affects sleep improvement in critically ill patients.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1036731423001558

The efficacy of earplugs and eye masks for delirium ... Conclusion. The overnight use of eye masks and earplugs were found to have positive effects on sleep quality domains (sleep disturbance, sleep effectiveness, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07010718

NCT07010718 | Improving Sleep in a Psychiatric Hospital The purpose of this study is to examine effects of sleep promotion versus treatment as usual (TAU) on subjective, self-reported sleep while in inpatient ...

4. brieflands.com brieflands.com/articles/msnj-144370

Comparison of the Effect of Swedish Massage and ... The data in this study indicated that compared to the earplug/eye mask group intervention, Swedish massage had a greater effect on improving the sleep quality ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2023/12290/different_nursing_interventions_on_sleep_quality.34.aspx

Different nursing interventions on sleep quality among... Eye masks and earplugs + eye masks were associated with improved sleep quality compared to routine care intervention (P < .05). Conclusions: In ...

6. researchgate.net researchgate.net/publication/270512968_The_effect_of_earplugs_and_eye_mask_on_patients'_perceived_sleep_quality_in_intensive_care_unit

The effect of earplugs and eye mask on patients' perceived ... Effect of the intervention on sleep effectiveness was positive, and there were significant differences (P < 0.001) between treatment night and ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2796565

Evaluation of Nonpharmacologic Interventions and Sleep ... The findings of this study suggest that sleep of hospitalized patients may be significantly improved with nonpharmacologic interventions.