Trial Outcomes & Findings for Nurse Suicide: Physiologic Sleep Health Promotion Trial (NCT NCT06079853)

Results Overview

This outcome measures the number of participants who had a score greater than 0 on the CSSRS at Baseline (Week 1). CSSRS total score range is from 0-6, with the higher number indicating more intense ideation. Any score above 0 indicates a positive ideation in the past month.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Baseline: Week 1

Results posted on

2024-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Single arm participants will receive the intervention PureSomni Sleep Health Product Kit: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nurse Suicide: Physiologic Sleep Health Promotion Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=25 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Age, Continuous	45.2 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants
Maslach Burnout Inventory (Subscale: Emotional Exhaustion) Baseline	31.2 units on a scale STANDARD_DEVIATION 11.72 • n=5 Participants
Maslach Burnout Inventory (Subscale: Depersonalization) Baseline	10.84 units on a scale STANDARD_DEVIATION 6.17 • n=5 Participants
Maslach Burnout Inventory (Subscale: Personal Accomplishment) Baseline	44.92 units on a scale STANDARD_DEVIATION 7.49 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline: Week 1

This outcome measures the number of participants who had a score greater than 0 on the CSSRS at Baseline (Week 1). CSSRS total score range is from 0-6, with the higher number indicating more intense ideation. Any score above 0 indicates a positive ideation in the past month.

Outcome measures

Outcome measures
Measure	Experimental n=25 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation	2 Participants

PRIMARY outcome

Timeframe: Follow-up: Week 4

This outcome measures the number of participants who had a score greater than 0 on the CSSRS at Follow-up (Week 4). CSSRS total score range is from 0-6, with the higher number indicating more intense ideation. Any score above 0 indicates a positive ideation in the past month.

Outcome measures

Outcome measures
Measure	Experimental n=25 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation	0 Participants

PRIMARY outcome

Timeframe: Follow-up: Week 8

This outcome measures the number of participants who had a score greater than 0 on the CSSRS at Follow-up (Week 8). CSSRS total score range is from 0-6, with the higher number indicating more intense ideation. Any score above 0 indicates a positive ideation in the past month.

Outcome measures

Outcome measures
Measure	Experimental n=24 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation	0 Participants

PRIMARY outcome

Timeframe: 8 weeks

Participants will wear the OuraRing to capture physiologic continuous heart rate variability. Heart rate variability is the variance in time between heart beats (RR intervals on an EKG) and is calculated using root mean square of successive differences between heartbeats. The middle 50% of 20-25 year olds usually have an average HRV in the 55-105 range, while 60-65 year olds tend to be between 25-45. In general, a higher heart rate variability is considered better as it indicates a more adaptable and resilient autonomic nervous system, which can respond effectively to different stressors. We calculated the mean difference between the control time period (Week1-4) and the intervention time period (Week 5-8).

Outcome measures

Outcome measures
Measure	Experimental n=25 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Physiologic Stress Response- Heart Rate Variability [Group Mean Difference Between Week 1-4(Control) and Week 5-8(Intervention)]	0.846 milliseconds Standard Deviation 5.424

PRIMARY outcome

Timeframe: baseline-Week 1

Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.

Outcome measures

Outcome measures
Measure	Experimental n=25 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)	8.30 score on a scale Standard Deviation 3.91

PRIMARY outcome

Timeframe: Follow up- Week 4

Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.

Outcome measures

Outcome measures
Measure	Experimental n=25 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)	6.79 score on a scale Standard Deviation 3.37

PRIMARY outcome

Timeframe: Follow up- Week 8

Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.

Outcome measures

Outcome measures
Measure	Experimental n=24 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)	5.85 score on a scale Standard Deviation 3.03

PRIMARY outcome

Timeframe: 8 weeks

This is to measure the average amount of daily sleep (hours) over an 8 week period. The physiologic data is collected via a wearable device (OuraRing). We calculated the mean difference in sleep duration (hours) between Week 1-4 (Control time period) and Week 5-8(Intervention time period).

Outcome measures

Outcome measures
Measure	Experimental n=24 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Physiologic Sleep Data - Sleep Duration (Mean Daily Hours)	6.81 Hours Standard Deviation 0.831

PRIMARY outcome

Timeframe: 8 Weeks

Total number of participants with at least 1 suicidal behavior that occurred during the given time period of 8 weeks.

Outcome measures

Outcome measures
Measure	Experimental n=25 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Number of Participants With at Least 1 Suicidal Behavior (Frequency)	0 participants

SECONDARY outcome

Timeframe: Baseline- Week 1

Scaling - Self report survey (subscale 1-emotional exhaustion) 7 point Likert Scale; Score Range 0-42 Interpretation: 17 or less - Low level of burnout 18-29 - Moderate level of burnout Greater than 30 - High level of burnout

Outcome measures

Outcome measures
Measure	Experimental n=25 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score	31.2 score on a scale Standard Deviation 11.72

SECONDARY outcome

Timeframe: Baseline- Week 1

Scaling - Self report survey (subscale 2-Depersonalization) 7 point Likert Scale; Score Range 0-42 Interpretation: 5 or less - Low level of burnout 6-11 - Moderate level of burnout Greater than 12 - High level of burnout

Outcome measures

Outcome measures
Measure	Experimental n=25 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score	10.84 score on a scale Standard Deviation 6.17

SECONDARY outcome

Timeframe: Baseline- Week 1

Scaling - Self report survey (subscale 3-Personal Achievement) 7 point Likert Scale; Score Range 0-48 Interpretation: 33 or less - Low level of burnout 34-39 - Moderate level of burnout Greater than 40 - High level of burnout

Outcome measures

Outcome measures
Measure	Experimental n=25 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Burnout Screening Via Maslach Burnout Inventory (Subscale 3: Personal Accomplishment) - Mean Composite Score	44.92 score on a scale Standard Deviation 7.49

SECONDARY outcome

Timeframe: Week 8

Scaling - Self report survey (subscale 1-emotional exhaustion) 7 point Likert Scale; Score Range 0-42 Interpretation: 17 or less - Low level of burnout 18-29 - Moderate level of burnout Greater than 30 - High level of burnout

Outcome measures

Outcome measures
Measure	Experimental n=25 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score	29 score on a scale Standard Deviation 14.4

SECONDARY outcome

Timeframe: Week 8

Scaling - Self report survey (subscale 2-Depersonalization) 7 point Likert Scale; Score Range 0-42 Interpretation: 5 or less - Low level of burnout 6-11 - Moderate level of burnout Greater than 12 - High level of burnout

Outcome measures

Outcome measures
Measure	Experimental n=25 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score	10.88 score on a scale Standard Deviation 5.69

SECONDARY outcome

Timeframe: Week 8

Scaling - Self report survey (subscale 3-Personal Achievement) 7 point Likert Scale; Score Range 0-48 Interpretation: 33 or less - Low level of burnout 34-39 - Moderate level of burnout Greater than 40 - High level of burnout

Outcome measures

Outcome measures
Measure	Experimental n=25 Participants Single arm pilot sample will receive intervention PureSomni Sleep Health Product Kit: PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs
Burnout Screening Via Maslach Burnout Inventory (Subscale 3: Personal Achievement) - Mean Composite Score	44.29 score on a scale Standard Deviation 9.5

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Allison A. Norful

Columbia University School of Nursing

Phone: 2123057157

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place