Improving Sleep in a Psychiatric Hospital

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07010718
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Mental Health Issue
  • Sleep Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Scented Oil — DRUG
    inpatient-safe aromatherapy (scented oil)
  • Ear Plugs — DEVICE
    ingestible-safe ear plugs (noise blocking)
  • Eye Mask — DEVICE
    inpatient-safe eye mask (light blocking).
  • Video based safety check — BEHAVIORAL
    video based safety checks will be conducted as long as participants are in bed and asleep
  • In person safety check — BEHAVIORAL
    In person safety checks will be conducted every 30 minutes

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
May 2025
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: 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
  • Active Comparator: Treatment as usual
    Only in person safety check will be conducted

Primary Outcome Measure

Change in nighttime Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Admission, Discharge (about 2 weeks after admission ) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Michelle Patriquin, PhD, ABPP
[email protected]
713-486-2700
Jessica Badawi
[email protected]
(713) 486-2700

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The University of Texas Health Science Center at Houston· Houston, TX

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