NCT07010718

Improving Sleep in a Psychiatric Hospital

Comparative Effectiveness Trial of Sleep Promotion vs. Disruption in High Suicide Risk Inpatients

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2025-06-08
• Last updated: 2025-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study