Sleep Coach App for Sleeplessness

1
Effectiveness
1
Safety
University of Michigan Rogel Cancer Center, Ann Arbor, MI
Sleeplessness+4 More
Sleep Coach App - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Sleeplessness

Study Summary

This study is evaluating whether a smartphone app can help people with insomnia.

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Eligible Conditions

  • Sleeplessness
  • Sleep Initiation and Maintenance Disorders
  • Prostate Cancer
  • Insomnia
  • Breast Cancer
  • Malignant Neoplasm of Colon

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Sleep Coach App will improve 3 primary outcomes and 1 secondary outcome in patients with Sleeplessness. Measurement will happen over the course of baseline to 7 weeks.

7 weeks
Percentage of participants engaging with the app at least 4 days/week
Percentage of participants satisfied with the intervention
Percentage of participants that find the intervention useful
baseline to 7 weeks
Effect size of the intervention as measured by the Insomnia Severity Index (ISI).

Trial Safety

Trial Design

2 Treatment Groups

Control
MI Sleep Coach Mobile Application

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sleep Coach App 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.

MI Sleep Coach Mobile Application
Behavioral
The Sleep Coach app includes evidence-based CBT-I strategies, interactive activities and a computerized dialogue agent to engage users in the adoption of and adherence to CBT-I strategies.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 7 weeks for reporting.

Closest Location

University of Michigan Rogel Cancer Center - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18 years of age or older
Has completed curative-intent treatment (chemo, surgery, RT) for prostate, colon or breast cancer at least three months and not more than 5 years prior to study entry. Note: Ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex), Herceptin and maintenance therapies are allowed.
Ability to read and write English
Ability to complete questionnaire(s) by themselves or with assistance.
Reports trouble falling asleep or staying asleep on at least 3 nights per week (most weeks) for the last 3 months.
Own an Android phone version 8 or higher (The latest version of Android is 11.0) or an iPhone running iOS 11 or higher (The latest version of iOS is 14.3.)
Ability to provide informed written consent.

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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The most frequent symptoms of insomnia are: insomnia, difficulty concentrating, and depressed mood. Insomnia may be related to a poor quality of life and may be an indicator of underlying psychiatric disorders, so it is important to understand that insomnia symptomatology is a common symptom that can be associated with a whole range of other psychiatric disorders. Insomnia is frequently misdiagnosed and therefore the treatment of sleeplessness could have beneficial effects for patient's mental health.

Unverified Answer

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

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Estimates of sleep disordered breathing are unreliable and inaccurate. They are heavily skewed towards men due to the prevalence and prevalence of sleep disordered breathing (a significant factor is that female patients are less likely to seek counseling regarding such a problem than male patients). While the incidence of sleep disordered breathing is declining in women, the percentage of men who have sleep disordered breathing is increasing due to the aging of the population. Thus, the overall percentage of patients with sleep disordered breathing will continue to rise. Sleep-disordered breathing causes a large number of health complaints that are unrecognized. Improving the understanding of sleep disordered breathing among healthcare providers presents a major opportunity for improved patient care.

Unverified Answer

Can sleeplessness be cured?

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Many studies have been done and not all have yielded positive results. A placebo was prescribed for all patients and was monitored for side effect on the night the patient slept. The placebo group was monitored and found to have a shorter sleep duration and duration of quiet sleep compared with the placebo group.

Unverified Answer

What are common treatments for sleeplessness?

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Insomnia can be treated by medications that may improve sleep and in many cases, worsen the sleep. Patients often complain that these medications cause side-effects. Patient education and training can help to reduce some of these issues. As with almost all medications, the risks outweigh the benefits of some drugs for sleepiness, including the risk of heart disease and increased vulnerability to falls. Other common treatments for insomnia are cognitive behavioral therapy (CBT) and relaxation techniques. There is no cure for insomnia, but treatment options are targeted more towards improving sleep quality.

Unverified Answer

What is sleeplessness?

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Sleep disturbances are common among adults in the US, with 7 percent reporting sleeping less than 5 hours and 34 percent reporting sleeping less than 7 hours nightly. Most sleep disturbance occurs as a consequence of insomnia. Individuals with sleep problems appear to be at a higher risk of developing or worsening depression.

Unverified Answer

What causes sleeplessness?

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There is a lack of clarity on the question of the cause of sleeplessness. The common suggestion of insufficient sleep and the idea that sleep deprivation increases risk of illness, injury, or mental health issues are neither correct or plausible for most cases of sleeplessness. Our approach to sleeplessness is to first exclude known, treatable causes and, where that cannot be done, try to identify and treat the underlying cause of sleeplessness in order to reduce risk in the long term.

Unverified Answer

What is the latest research for sleeplessness?

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In this review article, the latest research about the topic was described. The available data on the subject suggests that people who routinely get 3 or more hours of sleep each night have increased cortisol secretion, leading to a range of physiological effects. Atypical sleep pattern is evident among people who report short sleep duration or short sleep duration with daytime naps. The review concludes by stating that the research indicates that an improved sleep pattern seems to have a positive influence on a person's overall well-being. However, poor sleep in older people can be related to psychiatric problems such as depression, and for this reason, sleep hygiene remains of major importance for many elderly citizens.

Unverified Answer

Have there been any new discoveries for treating sleeplessness?

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There is very little evidence to support the effectiveness of a number of alternative'sleep medications'. There are no convincing studies available to show that certain products with the claim to treat sleeplessness are helpful, and may cause harm by overstimulating the body's systems involved in sleep regulation.

Unverified Answer

What is the primary cause of sleeplessness?

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In men and women of all age groups, a high percentage of people with unexplained sleeplessness say that they do not use or rely on the most common known reasons for sleep debt. In men and women of all age groups, the following are the most common: work factors, unhealthy sleep hygiene, stress and worry, sleep interruptions, and physical problems. In a recent study, findings highlight the need to more closely examine the psychological and social causes of sleeplessness.

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Have there been other clinical trials involving sleep coach app?

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The current study showed that a sleep coach app is effective in the improvement of sleepiness. More well-designed and bigger sample studies are necessary to validate the current findings.

Unverified Answer

Does sleep coach app improve quality of life for those with sleeplessness?

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A self-administered, patient-rated, 8-week, prospective study assessed the impact of SleepCoach on sleep, QoL, and physical health. The SleepCoach app was well received. QoL and sleep improved after 6 weeks of use, but changes in the QoL questionnaire did not reach statistical significance. Sleep coach is currently being studied in a larger trial. Clinicians may consider it for patients with sleep complaints.

Unverified Answer

Who should consider clinical trials for sleeplessness?

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A small number of patients who have tried all available treatment options for sleeplessness still experience sleep difficulties and should consider clinical trials for treatments to treat this disabling symptom. In the United States, [Federal National Institute of Neurological Disorders and Stroke (NINDS)] conducts research to develop treatments for sleep disorders, including sleep apnea hypopnea, restless leg syndrome, narcolepsy, and insomnia, and other sleep conditions such as restless legs syndrome. These trials compare different therapeutic treatments in patients with sleep disorders. They are [conducted at] [the NIH Clinical Center, National Institutes of Health, Bethesda, Maryland] (https://clinicaltrials.gov/).

Unverified Answer
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