Trial Outcomes & Findings for SleepSMART for Veterans With MCI and Insomnia (NCT NCT05016960)

NCT ID: NCT05016960

Last Updated: 2026-01-21

Results Overview

Rating scale assessing intervention appropriateness; scores range from 1-5 with higher scores indicating higher levels of appropriateness. Mean scores were calculated. No statistical analyses were performed.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
• Results posted on: 2026-01-21

Participant Flow

Veterans aged 60 or older with MCI and insomnia were recruited from VA San Diego health clinics between 12/07/2021 and 12/31/2023.

Enrolled participants were excluded from the treatment phase (phase 2) if they did not meet study eligibility criteria at pre-treatment assessment.

Participant milestones

Measure	Phase 1 - Sleep-SMART Development Phase 1 involved conducting a focus group with Veterans from the target population to inform development of the Sleep-SMART intervention and manual.	Phase 2 - Sleep-SMART Treatment Phase 2 involved piloting the Sleep-SMART treatment that was developed in Phase 1. Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Overall Study STARTED	5	25
Overall Study COMPLETED	4	16
Overall Study NOT COMPLETED	1	9

Reasons for withdrawal

Measure	Phase 1 - Sleep-SMART Development Phase 1 involved conducting a focus group with Veterans from the target population to inform development of the Sleep-SMART intervention and manual.	Phase 2 - Sleep-SMART Treatment Phase 2 involved piloting the Sleep-SMART treatment that was developed in Phase 1. Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Overall Study Withdrawal by Subject	1	9

Baseline Characteristics

Data was analyzed for treatment completers (n=16).

Baseline characteristics by cohort

Measure	Phase 2 - Sleep-SMART Treatment n=25 Participants Participants in Phase 2 received the Sleep-SMART treatment intervention and were administered baseline measures. Baseline and outcome measures were not collected as part of Phase 1.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Race (NIH/OMB) Black or African American	3 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Race (NIH/OMB) White	12 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Age, Categorical <=18 years	0 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Age, Categorical Between 18 and 65 years	4 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Age, Categorical >=65 years	12 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Sex: Female, Male Female	3 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Sex: Female, Male Male	13 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Race (NIH/OMB) Asian	1 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Race (NIH/OMB) More than one race	0 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=16 Participants • Data was analyzed for treatment completers (n=16).
Region of Enrollment United States	25 Participants n=25 Participants
Insomnia Severity Index	19.40 units on a scale STANDARD_DEVIATION 4.95 • n=16 Participants • Data was analyzed for treatment completers (n=16)

PRIMARY outcome

Timeframe: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Self-report scale to assess level of client satisfaction for the intervention. Scores range from 8-32, higher score indicates higher satisfaction. Mean scores were calculated at post-treatment. No statistical analyses were performed.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=14 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Client Satisfaction Questionnaire (CSQ-8)	29.43 score on a scale Standard Deviation 2.95

PRIMARY outcome

Timeframe: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 13 participants as 3 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Scale to assess the usability of telehealth to deliver the intervention. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree To determine the usability of the telehealth system, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the telehealth system.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=13 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Telehealth Usability Questionnaire (TUQ)	5.92 score on a scale Standard Deviation 1.15

PRIMARY outcome

Timeframe: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Rating scale assessing intervention acceptability; scores range from 1-5 with higher scores indicating higher levels of acceptability. Ratings were collected at post-treatment. Mean scores were calculated. No statistical analyses were performed.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=14 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Acceptability of Intervention Measure (AIM)	4.39 score on a scale Standard Deviation 0.59

PRIMARY outcome

Timeframe: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Rating scale assessing intervention appropriateness; scores range from 1-5 with higher scores indicating higher levels of appropriateness. Mean scores were calculated. No statistical analyses were performed.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=14 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Intervention Appropriateness Measure (IAM)	4.41 score on a scale Standard Deviation .66

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Self-report scale assessing Subjective level of disability. Scores range from 0-100, where 0 = no disability; 100 = full disability.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=14 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) Pre treatment	62.50 score on a scale Standard Deviation 17.105
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) Post treatment	63.79 score on a scale Standard Deviation 16.192

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Self-report scales assessing subjective cognitive complaints and subjective everyday functioning. Each response option is assigned a value (e.g., 1=Not at all). To find the total raw score, sum the values of the response to each question. A higher Neuro-QoL score represents more of the concept being measured - higher scores indicate worse functioning for the cognition scale.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=14 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Quality of Life in Neurological Disorders (Neuro-QOL) Cognition Scale Pre treatment	24.86 score on a scale Standard Deviation 8.047
Quality of Life in Neurological Disorders (Neuro-QOL) Cognition Scale Post treatment	26.57 score on a scale Standard Deviation 5.734

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Collateral measure of cognitive and everyday functioning. Is a 39 item questionnaire used to measure a patient's cognitive function and aid in the detection and diagnosis of dementia and other neurodegenerative diseases that are associated with aging. Each item is answered on a 1-4 point scale with a minimum total raw score of 39 and a maximum score of 156. Higher score are indicative of worse functioning.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=14 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Everyday Cognition Scale (ECoG) Post treatment	83.71 score on a scale Standard Deviation 30.19
Everyday Cognition Scale (ECoG) Pre Treatment	89.86 score on a scale Standard Deviation 34.576

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Self-report scale assessing perceived insomnia severity; scores range from 0-28 with higher scores indicating more severe insomnia.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=16 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Insomnia Severity Index (ISI) Pre-treatment	19.40 score on a scale Standard Deviation 4.95
Insomnia Severity Index (ISI) End of treatment	8.87 score on a scale Standard Deviation 6.89

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 13 participants as 3 of the 16 treatment completers from phase 2 did not complete the outcome measure.

The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. The Global PSQI score ranges from 0 to 21 with higher scores indicating poorer sleep quality.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=13 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Pittsburgh Sleep Quality Index (PSQI) Pre-treatment	11.69 score on a scale Standard Deviation 5.10
Pittsburgh Sleep Quality Index (PSQI) Post-treatment	8.85 score on a scale Standard Deviation 3.16

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Performance based measure of auditory attention; raw scores range from 0-48 with higher scores indicating better performance.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=14 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span (Total Raw Score) Pre-treatment	22.79 score on a scale Standard Deviation 6.841
Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span (Total Raw Score) Post-treatment	22.21 score on a scale Standard Deviation 6.739

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 9 participants as 7 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Performance based measure of Visual design learning and memory. Scores are based on individual performance and range from 0-36 with higher scores indicating better performance/memory.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=9 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Brief Visuospatial Memory Test-Revised (Total Recall Raw Score) Pre-treatment	14.33 score on a scale Standard Deviation 5.454
Brief Visuospatial Memory Test-Revised (Total Recall Raw Score) Post-treatment	16.00 score on a scale Standard Deviation 5.074

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 8 participants as 8 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test and range from <3 seconds to 240 seconds. Raw scores are presented in seconds with lower scores indicating better performance.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=8 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number-letter Switching) Raw Score Pre-treatment	146.63 seconds Standard Deviation 46.745
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number-letter Switching) Raw Score Post-treatment	140.13 seconds Standard Deviation 54.038

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 12 participants as 4 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Performance based measures of executive function (i.e., category switching total raw score). The task requires participants to alternate between generating words from two different semantic categories. Scores are based on the number of correct words generated. Total raw scores range from 0 to >21, with higher scores indicating better performance.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=12 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (Category Switching) Pre-treatment	12.25 words generated Standard Deviation 2.417
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (Category Switching) Post-treatment	11.75 words generated Standard Deviation 1.712

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Performance based measure of verbal list learning and memory (i.e., delayed recall raw score). Scores range from 0 to 12 with higher scores indicating better performance.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=14 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Hopkins Verbal Learning Test-Revised (Delayed Recall Raw Score) Pre-treatment	6.93 words recalled Standard Deviation 3.13
Hopkins Verbal Learning Test-Revised (Delayed Recall Raw Score) Post-treatment	7.14 words recalled Standard Deviation 2.69

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 9 participants as 7 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Performance based measure of Visual design learning and memory. Scores are based on individual performance and range from 0 to 12. Higher scores indicate better performance/memory.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=9 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Brief Visuospatial Memory Test-Revised (Delayed Recall Raw Score) Pre-treatment	5.44 correctly recalled elements Standard Deviation 2.5
Brief Visuospatial Memory Test-Revised (Delayed Recall Raw Score) Post-treatment	6.56 correctly recalled elements Standard Deviation 2.3

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Performance based measure of verbal list learning and memory (i.e., immediate recall raw score). Scores range from 0 to 36 with higher scores indicating better performance.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=14 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Hopkins Verbal Learning Test-Revised (Total Immediate Recall Raw Score) Pre-treatment	22.00 words recalled Standard Deviation 5.55
Hopkins Verbal Learning Test-Revised (Total Immediate Recall Raw Score) Post-treatment	21.0 words recalled Standard Deviation 2.37

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 9 participants as 7 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test. Raw scores are presented in seconds with lower scores indicating better performance.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=9 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number Sequencing) Pre-treatment	53.11 seconds Standard Deviation 17.43
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number Sequencing) Post-treatment	47.33 seconds Standard Deviation 25.96

OTHER_PRE_SPECIFIED outcome

Timeframe: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Population: Note: Data was analyzed for 9 participants as 7 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test. Raw scores are presented in seconds with lower scores indicating better performance.

Outcome measures

Measure	Phase 2 - Sleep-SMART Treatment n=9 Participants Sleep-SMART is a telehealth-based treatment for insomnia that follows the standard 6 session 50-minute CBT-I format and delivers CBT-I treatment along with training in select CogSMART cognitive strategies to enhance intervention learning and adherence.
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Letter Sequencing) Pre-treatment	65.22 seconds Standard Deviation 32.82
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Letter Sequencing) Post-treatment	46.44 seconds Standard Deviation 15.75

Adverse Events

Sleep-SMART

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

Dr. Erin Almklov

VA San Diego Healthcare System

Phone: 858-552-8585

Email: erin.almklov@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place