Sleep VS for Sleeplessness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sleep Center; Fontana Medical Center, Kaiser Permanente, Fontana, CA
Sleeplessness+13 More
Sleep VS - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new way to measure sleep quality can help doctors recognize sleep disorders.

See full description

Eligible Conditions

  • Sleeplessness
  • Insomnia
  • Obstructive Sleep Apnea (OSA)
  • Hypersomnia Type; Sleep Disorder
  • Restless Legs Syndrome (RLS)
  • Shift-work related sleep disturbance

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Sleeplessness

Study Objectives

This trial is evaluating whether Sleep VS will improve 1 primary outcome and 4 secondary outcomes in patients with Sleeplessness. Measurement will happen over the course of Every time patient completes the Sleep VS survey packet over a 3 month period..

3 months
Medications and Encounters
Referral Rates
Sleep Disorder Identification Rates
Month 3
Assessing response to treatment using Sleep VS
Sleep VS vs Sleep Questionnaires

Trial Safety

Safety Progress

1 of 3

Other trials for Sleeplessness

Trial Design

2 Treatment Groups

Usual Care
1 of 2
Sleep VS
1 of 2
Active Control
Experimental Treatment

This trial requires 1000 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sleep VS 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 VS
Other
Patients check-in for their primary care physician visit and are provided a Sleep VS survey packet. Investigators or research associates will review the Sleep VS, and patients that screen positive on their Sleep VS will be asked to complete an extended set of sleep questions. A triaging algorithm will be available based on answers to the extended sleep questions to assist the primary care physician with assessment and triaging care. Patients that screen "negative" will not be asked the extended sleep questions nor will they be brought to the attention of the primary care physician and proceed with "usual care."
Usual CarePatients check-in for their primary care physician visit and proceed with "usual care". Although the sleep vital sign will not be collected, the medical providers can still use the extended sleep questionnaire and triaging algorithm, if in the course of caring of the patient a potential sleep disorder is recognized.

Trial Logistics

Trial Timeline

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

Who is running the study

Principal Investigator
D. H.
Dennis Hwang, MD
Kaiser Permanente

Closest Location

Sleep Center; Fontana Medical Center, Kaiser Permanente - Fontana, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients that have a scheduled office visit with their primary care physician.
Patients have to be Kaiser Permanente members

Patient Q&A Section

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

"Almost 6 million Americans have insomnia, with one in five adults suffering from daytime sleepiness. The American Medical Association considers excessive daytime sleepiness to be a major public health concern. In a 2007 survey of nearly 4,000 adults, it was found that nearly 8% of subjects had excessive daytime sleepiness. The frequency of sleep disorders differs by region as well. The prevalence of insomnia varies by age, with nearly one in seven adults reporting sleep disturbance. This is a more serious problem among middle-aged and older adult groups, as well. In addition to sleepiness during the day, people who report sleeping during the night also had higher levels of sleepiness during the day." - Anonymous Online Contributor

Unverified Answer

What is insomnia?

"Insomnia is a chronic sleep disturbance characterised by excessive daytime sleepiness. It is strongly related to other sleep disorders and behavioural, psychosocial and clinical disorders but the underlying pathophysiology is not fully understood. Insomnia affects 3% of men in the USA and is thought to contribute significantly to general morbidity and economic cost. This article describes the main clinical characteristics and diagnostic procedures used to identify sleeplessness and sleep disorders. The authors urge that the term 'drowsiness' used at present to describe insomnia should be replaced by'severe sleepiness' in clinical trials and the literature to avoid inappropriate treatment with hypnotics and sleep augmentation." - Anonymous Online Contributor

Unverified Answer

What are the signs of insomnia?

"Insomnia is a symptom of many conditions, and its presence should prompt medical evaluation. Insufficient sleep is associated with an increased body mass index and waist circumference, two well-known risk factors for heart disease. Insomnia and daytime sleepiness may also be indicative of medical conditions such as depression, Alzheimer's disease, epilepsy, migraine, narcolepsy and sleep apnea." - Anonymous Online Contributor

Unverified Answer

What causes insomnia?

"Insomnia is a symptom of many disorders, but most commonly of the following: insomnia of a primary origin, secondary to other CNS problems, secondary to medication side effects, and secondary to excessive daytime sleepiness or sleep disordered breathing. Insomnia is seen in many groups of people, but some of its most consistent and alarming characteristics are that it is relatively common, it is chronic, it has major adverse effects on health and quality of life, and it can be a significant public health problem in societies. This paper gives recommendations for clinicians to help patients better manage insomnia that is caused by these common disorders and for individuals to develop effective, personalized coping strategies to help them get the rest they need to achieve and maintain higher-quality sleep." - Anonymous Online Contributor

Unverified Answer

Can insomnia be cured?

"Results from a recent paper, the majority of participants reported an improvement in their sleep, regardless of whether their baseline score was above or below a certain cut-off point. For participants with severe insomnia, a meaningful improvement was observed regardless of baseline score. In all, 42% of participants reported an improvement of their sleep quality following pharmacotherapy." - Anonymous Online Contributor

Unverified Answer

What are common treatments for insomnia?

"Treatment of insomnia often involves multiple methods. A low- to moderate-risk category of antidepressants also may be effective, depending on severity. Many patients benefit from a combination of relaxation and cognitive behavioural therapy. In some, cognitive behavioural therapy alone may be effective. The benefit and necessity of discontinuing hypnotic drugs, and the role of medications in the long-term management of insomnia remain to be determined." - Anonymous Online Contributor

Unverified Answer

Does sleep vs improve quality of life for those with insomnia?

"QoL improves in people with insomnia compared to people without. Insomnia is associated with a decreased HRQoL and a decreased QoL regardless of the presence or absence of psychiatric diagnoses, especially depressive symptoms. Patients should be approached by their sleep specialist and offered behavioral or pharmacological sleep therapies that maximize HRQoL in addition to improvement in sleep quality." - Anonymous Online Contributor

Unverified Answer

Has sleep vs proven to be more effective than a placebo?

"In a large number of clinical studies using an objective sleep measurement, and a placebo control with a well-established standard treatment, no significant benefits were found over a placebo with respect to sleep duration or bedtime (even if the treatments were individually administered in a systematic way at specific times according to sleep chronometry measures)." - Anonymous Online Contributor

Unverified Answer

How does sleep vs work?

"It is imperative for people to make a conscious effort throughout the day to switch off the work-related activities completely. To put it another way: Sleep-related activities are not only to be avoided but, rather, all activities as stressful as daily chores and chores should always be avoided. For a long time, I kept a diary and wrote down when I slipped on track of time or when I woke up before 6 to be sure I did all these things and I managed not to fall asleep during all my other activities like school. As a result, I still slept all the time and did not spend that much time around other people. This is not a new skill I learned from other people, but it was new to me." - Anonymous Online Contributor

Unverified Answer

How serious can insomnia be?

"Over one third of the patients with insomnia in this study suffered from insomnia symptoms. The majority had insomnia at least four times a week. Of those, 20% of the insomnia symptoms were as severe as those recorded in the DSM-IV in the DSM category of major depressive disorder (MDD)." - Anonymous Online Contributor

Unverified Answer

Is sleep vs typically used in combination with any other treatments?

"Sleep may improve pain and other symptoms in patients with cancer. Further, an improvement in subjective pain-related quality of life was observed after sleep. However, this beneficial effect can be achieved with any of the typically used treatments, such as non-steroidal antiinflammatory drugs, analgesics, and even a low dose of steroids." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in sleep vs for therapeutic use?

"The use of a TTM in a sleep study is supported by the results of a systematic review of published studies. Moreover, studies have found a significant correlation between improvement of daytime insomnia and improvement in sleep and the number of hours in sleep has increased in recent studies. Therefore, evidence suggests that this approach is useful as a complementary tool to the evaluation of both the pharmacological and non-pharmacological therapies available now, which, in turn, may improve daytime sleepiness. On the other hand, the use of a TTM as a complementary therapy to the clinical and pharmacological evaluation in patients affected by non-adrenergic, non-cholinergic, central, and neurological disorders is still poorly established." - 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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