Sleep-SMART for Cognitive Decline

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VA San Diego Healthcare System, San Diego, CA, San Diego, CA
Cognitive Decline+3 More
Sleep-SMART - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a cognitive behavioral therapy for insomnia (CBT-I) can be adapted to help people with mild cognitive impairment (MCI) sleep better.

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Eligible Conditions

  • Cognitive Decline
  • Insomnia
  • Mild Cognitive Impairment (MCI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Sleep-SMART will improve 5 primary outcomes and 12 secondary outcomes in patients with Cognitive Decline. Measurement will happen over the course of Immediately before and immediately after the intervention.

Immediately after the intervention
Acceptability of Intervention Measure (AIM)
Client Satisfaction Questionnaire (CSQ-8)
Feasibility of Intervention Measure (FIM)
Intervention Appropriateness Measure (IAM)
Telehealth Usability Questionnaire (TUQ)
Immediately before and immediately after the intervention
Brief Visuospatial Memory Test-Revised
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test
Everyday Cognition Scale (ECoG)
Hopkins Verbal Learning Test-Revised
Independent Living Skills Survey (ILSS)
Pittsburgh Sleep Quality Index (PSQI)
Quality of Life Inventory (QOLI)
Quality of Life in Neurological Disorders (Neuro-QOL) cognition scale
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span
Immediately before the intervention, weekly during the intervention, and immediately after the intervention
Insomnia Severity Index (ISI)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Sleep-SMART
1 of 1
Experimental Treatment

This trial requires 31 total participants across 1 different treatment group

This trial involves a single treatment. Sleep-SMART is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Sleep-SMART
Behavioral
Sleep-SMART intervention

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately before and immediately after the intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly immediately before and immediately after the intervention for reporting.

Closest Location

VA San Diego Healthcare System, San Diego, CA - San Diego, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Veterans ages 60 or older who are competent to provide informed consent
The text discusses the chart diagnosis of MCI (mild cognitive impairment) based on previously published criteria. show original
The DSM-5 diagnosis of insomnia is given to individuals who have difficulty falling asleep, staying asleep, or who experience non-restorative sleep for at least three nights per week for at least three months show original
The ability to understand, speak, and read English fluently with little or no difficulty. show original

Patient Q&A Section

Can sleeplessness be cured?

"In this small pilot study in a primary care setting of patients with insomnia, there was a significant increase in sleep quality during the first month on the antidepressant, desipramine. Sleep quality in these depressed insomnia patients remained high after 6 months. These improvements in sleep quality were not attributable to changes in the levels of sleep duration, latency, or awakenings." - Anonymous Online Contributor

Unverified Answer

What are the signs of sleeplessness?

"Overall, the present data suggest that the main feature of sleeplessness is to have difficulty relaxing, not an inability to sleep. While sleep may sometimes be an aspect to consider, it doesn't appear that sleeplessness is an inherent feature." - Anonymous Online Contributor

Unverified Answer

What causes sleeplessness?

"Sleep is an important system requiring a highly efficient balance between the need for sleep and the desire to remain awake. The sleep/wake cycle is not self-sustaining and requires continuous input from the circadian clock to synchronize the biological rhythms to 24-hour environmental light-dark cycles." - Anonymous Online Contributor

Unverified Answer

What is sleeplessness?

"There are some important aspects of sleep quality that can be measured by the PSQI tool. These include: sleep latency time, time at sleep ends, and objectively obtained total sleep time. However, other important aspects are not well described through measurements of the PSQI. This could be because of its nature (a rating scale), because PSQI scales cover different psychological states such as sleeplessness, sleep-related disordered behaviours, insomnia, and other comorbid mood disorders (e.g., bipolar (BP))." - Anonymous Online Contributor

Unverified Answer

How many people get sleeplessness a year in the United States?

"Around 25 million adults report a typical night of sleep disturbances each year. In the United States, many people report sleepless nights every week and it has been asserted by many that sleeplessness is a major risk factor for chronic disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for sleeplessness?

"There is a large variability in the available treatment guidelines for sleepiness, especially in the use of psychotherapy. There is a need for consensus in order to advance research in this area." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of sleep-smart?

"The following side effects were reported by ≥30% of subjects: decreased appetite, insomnia, headache, irritability, constipation, and weight gain. More subjects reported the following side effects: drowsiness, depression, and fatigue. The following were reported by less than 10% of subjects and all side effects: diarrhea, vomiting, anorexia, rash, pruritus, dry mouth, urinary urgency and frequency, nausea, vomiting, and itchiness. Although side effects can be disturbing, many subjects can benefit from a better sleep pattern through sleep-smart." - Anonymous Online Contributor

Unverified Answer

What does sleep-smart usually treat?

"Most common prescriptions are ineffective for insomnia. Future research on the treatment of insomnia may focus on the efficacy of nonbenzodiazepine compounds like modafinil and narcolepsy medications for improving sleep." - Anonymous Online Contributor

Unverified Answer

How serious can sleeplessness be?

"Sleep-disordered breathing is not as common as the general population would lead us to believe. However, the effects of sleeplessness are relatively serious. The National Sleep Foundation advises staying 'on the job or school' if possible but in an effort to fall asleep by a reasonable amount, set priorities and take time to do so. Sleepiness was also more pronounced for men and those over the age of 60. However, sleep quality was more impaired for women and people under 60 years old. For insomnia sufferers, we have a better understanding of the factors that contribute to sleeplessness. This could lead to effective ways of combating sleeplessness that will reduce the negative impact it can have on one's health and life." - Anonymous Online Contributor

Unverified Answer

What is sleep-smart?

"Sleep-smart is a program for people with sleep challenges who are trying to get better sleep. Participants must self-monitor their sleep to find and stay on the sleep-smart path. It is one way to make your sleep a priority. The program features exercises/tips aimed at helping people get better sleep habits and help with their sleep challenges. For example, do not drink caffeine before your sleep time and stop spending so much time watching TV before bedtime. Sleep-smart was launched in January 2017 on the [Fashion Television Network. https://www.fashiontelevision.com.au/tv-shows/sleep-smart/. Date accessed: 18 November 2018." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in sleep-smart for therapeutic use?

"Advances in research indicate growing support for the therapeutic use of non-pharmacological treatments such as light therapy for insomnia in order to improve sleep quality. The use of light therapy could be considered as part of routine patient care as an effective approach to improving sleep quality." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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