Sleep DisorderPhase 1NCT07010718
Improving Sleep in a Psychiatric Hospital
A Phase 1 study testing Scented Oil, Ear Plugs and Eye Mask in people with Sleep Disorder and Mental Health Issue, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sleep Disorder, Mental Health Issue
- What is being tested?
- Scented Oil, Ear Plugs and Eye Mask
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Michelle Patriquin, PhD, ABPP, 713-486-2700, Michelle.A.Patriquin@uth.tmc.edu
Jessica Badawi, (713) 486-2700, Jessica.C.Badawi@uth.tmc.edu
About this study
Official title: Comparative Effectiveness Trial of Sleep Promotion vs. Disruption in High Suicide Risk Inpatients
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
- Being tested
- Scented Oil, Ear Plugs, Eye Mask, Video based safety check, In person safety check
- Keywords
- suicidal ideation
- Medical subject headings
- Sleep Wake Disorders, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scented OilDrug
inpatient-safe aromatherapy (scented oil)
Ear PlugsDevice
ingestible-safe ear plugs (noise blocking)
Eye MaskDevice
inpatient-safe eye mask (light blocking).
Video based safety checkBehavioural
video based safety checks will be conducted as long as participants are in bed and asleep
In person safety checkBehavioural
In person safety checks will be conducted every 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: In person safety check |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Admission, Discharge (about 2 weeks after admission )
Secondary outcomes (6)
Change in suicide risk as assessed by the Suicide Behaviors Questionnaire Revised (SBQ-R)
The SBQ-R is a 4-item questionnaire, each scored on a different scale. Total scores range from 3 to 18, with higher scores indicating greater suicide risk.
Item 1 is scored from 1 [Never (1 point)] to 6 [I have attempted to kill myself more than once (6 points)] Item2 is scored from 1[Never (1 point)] to 5[Very often (5 or more times) (5 points)] Item 3 is scored from 1[No (1 point)] to 5[Yes, more than once, and really wanted to do it (5 points)] Item 3 is scored from 1[Never (1 point)] to 6 [Rather likely (6 points)]
Measured: Admission, Discharge (about 2 weeks after admission )
Change in Suicide Ideation as assessed by the Beck Scale for Suicide Ideation (BSS)
The Beck Scale for Suicide Ideation (BSS) is a 21-item questionnaire. The first 19 items are scored from 0(No ideation/symptom) to 2 (Severe ideation/symptom) for a maximum score of 38, higher scores indicate greater severity of suicidal ideation.
The last 2 items assess past suicide attempts and intent to die during the most recent attempt. These are not included in the total score.
Measured: Admission, Discharge (about 2 weeks after admission )
Change in Anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) scale
The GAD-7 is a brief, 7-item questionnaire, and each is scored from 0(not at all) to 3( nearly every day) for a total score range of 0-21, higher score indicating severe anxiety symptoms
Measured: Admission, Discharge (about 2 weeks after admission )
Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a 9-item questionnaire, each is scored from 0( not at all) to 3(nearly every day) for a total score range of 0-27, higher scores indicate greater severity of depressive symptoms.
Measured: Admission, Discharge (about 2 weeks after admission )
Objective Nighttime Sleep Quantity as assessed by the Total Sleep Time (TST) via ActiGraph wGT3X-BT
Total Sleep Time (TST) is the total amount of actual sleep time recorded during the nighttime sleep period. This measure is objectively assessed using the ActiGraph wGT3X-BT, a validated wrist-worn accelerometer device that estimates sleep parameters based on movement data.TST is calculated as the sum of all sleep epochs during the main sleep period (typically nighttime) and is reported in minutes or hours.
Measured: Each night during length of stay (about 2 weeks)
Objective Nighttime Sleep Quality as assessed by the Nighttime Awakenings via ActiGraph wGT3X-BT
Nighttime Awakenings refer to the number and/or duration of awakenings during the main sleep period, objectively measured by the ActiGraph wGT3X-BT wrist-worn accelerometer. The device detects movement patterns to identify sleep interruptions, providing an estimate of sleep fragmentation and overall sleep quality.
The outcome will be reported as: Total number of awakenings per night
Measured: Each night during length of stay(about 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Patriquin, The University of Texas Health Science Center, Houston
- Investigators
- Michelle Patriquin, PhD, ABPP, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010718
- Sponsor's protocol ID
- HSC-MS-24-1035
- Status last verified
- May 2025
- First submitted
- 23 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Trial of Sleep Promotion vs. Disruption in High Suicide Risk Inpatients
- ClinicalTrials.gov ID
- NCT07010718
- Acronym / sponsor ID
- HSC-MS-24-1035
- Conditions
- Sleep Disorder, Mental Health Issue
- Keywords
- suicidal ideation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep promotion | Experimental | Drug: Scented Oil, Device: Ear Plugs, Device: Eye Mask, Behavioral: Video based safety check, Behavioral: In person safety checkScented 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 |
| Treatment as usual | Active comparator | Behavioral: In person safety checkOnly in person safety check will be conducted |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scented Oilinpatient-safe aromatherapy (scented oil) | Drug | Sleep promotion |
| Ear Plugsingestible-safe ear plugs (noise blocking) | Device | Sleep promotion |
| Eye Maskinpatient-safe eye mask (light blocking). | Device | Sleep promotion |
| Video based safety checkvideo based safety checks will be conducted as long as participants are in bed and asleep | Behavioural | Sleep promotion |
| In person safety checkIn person safety checks will be conducted every 30 minutes | Behavioural | Sleep promotion, Treatment as usual |
Primary outcome
Change in nighttime Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Admission, Discharge (about 2 weeks after admission )
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.
Change in insomnia as assessed by the Insomnia Severity Index (ISI)
Time frame: Admission, Discharge (about 2 weeks after admission )
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.
Change in daytime Sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
Time frame: Admission, Discharge (about 2 weeks after admission )
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.
6 secondary outcomes
Change in suicide risk as assessed by the Suicide Behaviors Questionnaire Revised (SBQ-R)
Time frame: Admission, Discharge (about 2 weeks after admission )
Change in Suicide Ideation as assessed by the Beck Scale for Suicide Ideation (BSS)
Time frame: Admission, Discharge (about 2 weeks after admission )
Change in Anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) scale
Time frame: Admission, Discharge (about 2 weeks after admission )
Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: Admission, Discharge (about 2 weeks after admission )
Objective Nighttime Sleep Quantity as assessed by the Total Sleep Time (TST) via ActiGraph wGT3X-BT
Time frame: Each night during length of stay (about 2 weeks)
Objective Nighttime Sleep Quality as assessed by the Nighttime Awakenings via ActiGraph wGT3X-BT
Time frame: Each night during length of stay(about 2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Patriquin, PhD, ABPP principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Scented Oil, Ear Plugs and Eye Mask in people with Sleep Disorder and Mental Health Issue, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Patriquin, PhD, ABPP ((713) 486-2700, Michelle.A.Patriquin@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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 )). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.