CBTi with Application for Sleeplessness

Phase-Based Estimates
1
Effectiveness
2
Safety
The Pennsylvania State University, University Park, PA
+3 More
CBTi with Application - CombinationProduct
Eligibility
18+
All Sexes
Eligible conditions
Sleeplessness

Study Summary

Enhanced CBTi for Older Adult Sleep and Cognition

See full description

Eligible Conditions

  • Sleeplessness
  • Alzheimer Disease
  • Sleep Initiation and Maintenance Disorders
  • Insomnia
  • Alzheimers Disease Related Dementias

Treatment Effectiveness

Study Objectives

This trial is evaluating whether CBTi with Application will improve 1 primary outcome, 2 secondary outcomes, and 4 other outcomes in patients with Sleeplessness. Measurement will happen over the course of Nightly (each night throughout study weeks 1-8).

Week 2
Change (pg/mL) in blood biomarkers of Alzheimer's-related dementia and Inflammation
Change in C-reactive Protein (CRP; mg/L)
Daily: Baseline (throught 1st-2nd study weeks) and Post-Treatment (throughout 8th study week)
Change in cognitive test battery performance
Daily: during Intervention (throughout 3rd-7th study weeks) and Post-Treatment (throughout 8th study week)
Adherence to clinical therapeutic prescription
Week 1
Change in Sleep Maintenance Efficiency
Change in Total Sleep Time
Week 1
Change in Insomnia Severity Index

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

5 Treatment Groups

CBTi (Active Control)
CBTi with Application

This trial requires 130 total participants across 5 different treatment groups

This trial involves 5 different treatments. CBTi With Application is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

CBTi with Application
CombinationProduct
Device-based intervention facilitation and clinician interfacing for Cognitive Behavioral Therapy for Insomnia (CBTi).
CBTi (Active Control)Standard CBTi delivered via video conferencing [Zoom Health], without electronic sleep diary app/dashboard [traditional pencil-and-paper diary instead], environmental cues, or live ambulatory device feedback to the clinician.
Passive ControlSleep hygiene education and training, without CBTi.
Sleep Hygiene
Behavioral
Treatment as usual: Sleep hygiene education and training.
CBTi
Behavioral
Standard CBTi delivered via video conferencing [Zoom Health].

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: daily: during intervention (throughout 3rd-7th study weeks) and post-treatment (throughout 8th study week)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly daily: during intervention (throughout 3rd-7th study weeks) and post-treatment (throughout 8th study week) for reporting.

Who is running the study

Principal Investigator
O. M. B.
Prof. Orfeu M. Buxton, Elizabeth Fenton Susman Professor of Biobehavioral Health
Penn State University

Closest Location

The Pennsylvania State University - University Park, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Insomnia Severity Index (ISI) screening survey score of >=11
Independent Living status (or equivalent; if dwelling in a community living facility)
Ability to complete (sign) own consent form
Fluent English speaker/reader
Age 60-90 (inclusive, at enrollment)
Willing to refrain from initiating new therapeutic insomnia interventions that are not a part of this study protocol for the duration of study participation
You are willing to participate in the study for the duration of the study. show original
Participants residing in a community living facility with a private and appropriate area for blood draw to occur are eligible for the optional blood draw portion of this research. show original

Patient Q&A Section

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

What are the signs of sleeplessness?

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Many different signs and symptoms can indicate sleeplessness. It seems that in those with chronic sleeplessness, there can be a need to get more sleep than the person is getting. There seem to be several ways to make sleep a more enjoyable experience and an essential part of everyday life.

Unverified Answer

Can sleeplessness be cured?

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Sleep fragmentation and nocturnal awakenings are common and well known phenomena of circadian rhythm sleep disorders. There are no absolute cures for insomnia. There are, however, many treatments, which can improve sleep quality. However, none of them can guarantee the full restoration of normal sleep patterns. Sleep fragmentation, which is observed more frequently in people suffering from depression, can be successfully treated with the use of antidepressants.

Unverified Answer

What are common treatments for sleeplessness?

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The causes of sleeplessness vary depending on the age and situation of one's own, and many treatments exist to remedy such problems. Sleep hygiene and sleep architecture therapy can be prescribed to patients who are not benefiting from others. Sleep deprivation can occur as a secondary effect in many patients' sleep deprivation. One should try to sleep only when required to maintain health and well-being. If treatment is not effective, one should address any underlying medical condition. Sleep architecture therapy can be considered a therapy to cure sleep insomnia.

Unverified Answer

What causes sleeplessness?

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If a large number of people get tired, that is only because the brain cannot adjust its demands for sleep. The sleep cycle, too, may only be partially controlled by the brain. However, it is not the amount of sleep but rather the frequency, quality, and pattern of sleep that are important for health. Sleep deprivation causes more illnesses than overeating in people over age 55. Some people may need to get up early in the morning to feel well rested for proper function. In this case, regular exercise can be recommended.

Unverified Answer

What is sleeplessness?

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Sleeplessness is a common condition, and is a symptom of certain medical conditions. It is most commonly attributed to stress, and is also associated with anxiety or depression. Sleep difficulties can have significant consequences for the well-being of individuals. It has been linked with many other conditions, and sleep problems may also contribute to the maintenance of other medical conditions, such as cardiovascular disease, diabetes mellitus, hypertension and certain types of cancer. In order to identify and treat sleep difficulties you may need to assess symptoms for other medical conditions, psychological condition and relationship status of person with sleep difficulties. The presentation of sleep problems may be complicated by psychiatric diagnoses. It is essential to discuss sleep problem with your doctor.

Unverified Answer

Is cbti with application safe for people?

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Recent findings suggest that a one-off application of Cbti at bedside to a medically fragile patient with CFT (and, if indicated after consultation with a clinical psychologist or psychiatrist, may be considered an integral part of treatment) is not likely to cause significant sleep disturbance for either the individual or the patient.

Unverified Answer

What are the latest developments in cbti with application for therapeutic use?

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The current and emerging areas of evidence on CBT use in insomnia are reviewed. Further research is needed to explore the effectiveness of CBT for insomnia and to clarify optimal use of the treatment for insomnia in clinical practice.

Unverified Answer

What is the latest research for sleeplessness?

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Sleeping difficulties can affect one's life and health. It is crucial to take a medical history and find out any medical history of the patient. After doing a comprehensive medical history, the clinician's next step is to search for comorbid conditions and other factors that may have an effect on the patient's sleep. Some of these comorbidities include gastrointestinal (GI) symptoms, anxiety, and stress. There has not been any specific medical test to determine why some patients have difficulty sleeping. Some of the symptoms that can affect sleep are GI problems, anxiety, depression, stress, fatigue, and insomnia.

Unverified Answer

How does cbti with application work?

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Results from a recent paper of the present study show that the therapeutic effect of application cbti in the management of insomnia is not only due to the subjective and objective evaluation of sleep structure and duration of sleep latency. It was shown that application cbti in the treatment of insomnia results in improvement in sleep quality and decrease sleep onset latency.

Unverified Answer

Who should consider clinical trials for sleeplessness?

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More than half of those with a history of sleep complaints (40%) and insomnia (30%) would benefit from clinical trial treatment for insomnia. Sleepiness is more common in women (61%) than in men (48%); however, the difference is not statistically significant. Sleep problems also appear to be more common among those with a higher education level and an optimistic attitude towards treatment.

Unverified Answer

Have there been other clinical trials involving cbti with application?

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Results from the two trials suggest there is no evidence from clinical trials to provide evidence that CBTI is an effective treatment for insomnia in children and young adults.

Unverified Answer
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