Improving Sleep in a Psychiatric Hospital

NCT ID: NCT07010718

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2028-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Disorder Mental Health Issue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Sleep promotion

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 Type EXPERIMENTAL

Scented Oil

Intervention Type DRUG

inpatient-safe aromatherapy (scented oil)

Ear Plugs

Intervention Type DEVICE

ingestible-safe ear plugs (noise blocking)

Eye Mask

Intervention Type DEVICE

inpatient-safe eye mask (light blocking).

Video based safety check

Intervention Type BEHAVIORAL

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

In person safety check

Intervention Type BEHAVIORAL

In person safety checks will be conducted every 30 minutes

Treatment as usual

Only in person safety check will be conducted

Group Type ACTIVE_COMPARATOR

In person safety check

Intervention Type BEHAVIORAL

In person safety checks will be conducted every 30 minutes

Interventions

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Scented Oil

inpatient-safe aromatherapy (scented oil)

Intervention Type DRUG

Ear Plugs

ingestible-safe ear plugs (noise blocking)

Intervention Type DEVICE

Eye Mask

inpatient-safe eye mask (light blocking).

Intervention Type DEVICE

Video based safety check

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

Intervention Type BEHAVIORAL

In person safety check

In person safety checks will be conducted every 30 minutes

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Michelle Patriquin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle Patriquin, PhD, ABPP

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Michelle Patriquin, PhD, ABPP

Role: CONTACT

(713) 486-2700

Jessica Badawi

Role: CONTACT

(713) 486-2700

Facility Contacts

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Michelle Patriquin, PhD, ABPP

Role: primary

713-486-2700

Jessica Badawi

Role: backup

(713) 486-2700

Other Identifiers

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HSC-MS-24-1035

Identifier Type: -

Identifier Source: org_study_id

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