Improving Sleep in a Psychiatric Hospital

NCT07010718 | Not Yet Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: HSC-MS-24-1035
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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 psychiatric treatment, to examine effects of sleep promotion vs. TAU/sleep disruption on self-reported depression, anxiety, suicide risk across inpatient length of stay, readmission at 72 hours, objective sleep and to compare implementation outcomes of acceptability and feasibility of sleep promotion relative to TAU/sleep disruption as reported by patients, clinicians, and clinic leaders using mixed methods.

Conditions

Sleep Disorder; Mental Health Issue

Keywords

suicidal ideation

Outcome Measures

Primary Outcomes (3)

• Change in nighttime Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)

  The PSQI has 19 self rated questions with a global score range of 0 to 21.It has 7 components and each is scored from 0 (no difficulty) to 3(severe difficulty) with higher scores indicating poorer sleep quality.

  Admission, Discharge (about 2 weeks after admission )

• Change in insomnia as assessed by the Insomnia Severity Index (ISI)

  The ISI is a 7-item , each item is rated on a 0 (no problem)-4 (very severe problem) scale, with total scores ranging from 0 to 28. Higher scores indicate greater insomnia severity.

  Admission, Discharge (about 2 weeks after admission )

• Change in daytime Sleepiness as assessed by the Epworth Sleepiness Scale (ESS)

  The ESS is an 8-item questionnaire. Each item is scored from 0 (would never doze) to 3 (high chance of dozing). The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.

  Admission, Discharge (about 2 weeks after admission )

Secondary Outcomes (6)

• Change in suicide risk as assessed by the Suicide Behaviors Questionnaire Revised (SBQ-R)

  Admission, Discharge (about 2 weeks after admission )

• Change in Suicide Ideation as assessed by the Beck Scale for Suicide Ideation (BSS)

  Admission, Discharge (about 2 weeks after admission )

• Change in Anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) scale

  Admission, Discharge (about 2 weeks after admission )

• Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9)

  Admission, Discharge (about 2 weeks after admission )

• Objective Nighttime Sleep Quantity as assessed by the Total Sleep Time (TST) via ActiGraph wGT3X-BT

  Each night during length of stay (about 2 weeks)

Study Arms (2)

Sleep promotion

EXPERIMENTAL

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

Drug: Scented Oil; Device: Ear Plugs; Device: Eye Mask; Behavioral: Video based safety check; Behavioral: In person safety check

Treatment as usual

ACTIVE COMPARATOR

Only in person safety check will be conducted

Behavioral: In person safety check

Interventions

Scented Oil DRUG

inpatient-safe aromatherapy (scented oil)

Sleep promotion

Ear Plugs DEVICE

ingestible-safe ear plugs (noise blocking)

Sleep promotion

Eye Mask DEVICE

inpatient-safe eye mask (light blocking).

Sleep promotion

Video based safety check BEHAVIORAL

video based safety checks will be conducted as long as participants are in bed and asleep

Sleep promotion

In person safety check BEHAVIORAL

In person safety checks will be conducted every 30 minutes

Sleep promotion; Treatment as usual

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted voluntarily to inpatient psychiatric hospital for suicidal ideation or behavior.
• Continue to express suicide risk on the Suicide Behaviors Questionnaire-Revised (SBQ-R) of ≥8 at admission.
• Cognitive ability as tested by the Montreal Cognitive Assessment (MoCA) of \> 23.
• Have sufficient communication and comprehension ability to consent to the study
• English speaking

You may not qualify if:

• Intellectual disability/unable to give informed consent.
• Patients with one-to-one supervision or 15-minute (Q15) safety checks for suicidality or aggression will be unable to enroll in the study until these restrictions are discontinued.
• Patients with roommates that are on one-to-one supervision or Q15 safety checks for suicidality or aggression.
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Suicidal Ideation

Interventions

Odorants; Ear Protective Devices

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Michelle Patriquin, PhD, ABPP

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Patriquin, PhD, ABPP

CONTACT

(713) 486-2700; Michelle.A.Patriquin@uth.tmc.edu

Jessica Badawi

CONTACT

(713) 486-2700; Jessica.C.Badawi@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 8, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)