Sleep Vital Sign Assessment for Sleep Disorders

(SSVS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance doctors' ability to recognize and track sleep disorders using a new tool called the Sleep Vital Sign (Sleep VS). Participants will complete a simple survey about their sleep during visits to their primary care doctor. Those showing signs of a sleep disorder will answer additional questions, aiding their doctor in determining the best care plan. The trial seeks Kaiser Permanente members with an upcoming visit to their primary care doctor. Participants must understand and complete the surveys in English. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve sleep disorder diagnosis and care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this sleep vital sign is safe for assessing sleep disorders?

Research shows that treating sleep as an important health indicator can help identify sleep disorders. This method doesn't involve new medications or invasive procedures, making it generally safe. The plan involves using a survey to help doctors better understand and manage sleep problems.

Previous studies highlight the importance of monitoring sleep patterns for overall health. Good sleep is essential for the body to function well, and sleep issues can lead to various health problems. These studies also suggest that unnecessary overnight checks in hospitals can disturb sleep, causing confusion and weakening the immune system.

The Sleep VS survey aims to reduce these disturbances by allowing healthcare providers to focus on sleep without interrupting it. Since this approach only involves surveys and questions, it is well-tolerated and avoids the side effects often associated with medications or medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep VS approach for sleep disorders because it introduces a proactive method for identifying sleep issues right in the primary care setting. Unlike the usual care where potential sleep problems might be overlooked unless specifically noticed by a doctor, Sleep VS uses a survey to screen patients systematically. This approach allows for early identification and triaging of care through an algorithm, potentially leading to faster and more accurate diagnoses. By integrating this screening tool, the Sleep VS enhances the standard care process, offering a streamlined way to address sleep disorders that might otherwise go undetected.

What evidence suggests that the Sleep VS is effective for recognizing sleep disorders?

Research has shown that sleep is vital for good health, and poor sleep can cause many health issues. Studies suggest that regular sleep assessments by doctors could lead to more effective detection and treatment of sleep problems. In this trial, participants in the Sleep VS arm will use the Sleep VS tool, designed to simplify the detection of sleep issues often overlooked during regular doctor visits. Unlike traditional sleep tests like polysomnography (PSG), which are complex, the Sleep VS offers a simpler way to screen for sleep problems. This new approach could help doctors better identify and manage sleep disorders, leading to improved health outcomes. Participants in the Usual Care arm will continue with their regular doctor visits without the Sleep VS tool. ^{2 4 6 7 8}

Who Is on the Research Team?

Dennis Hwang, MD

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for Kaiser Permanente members who have a scheduled visit with their primary care physician. It's aimed at those who may suffer from various sleep disorders like apnea or insomnia. Non-English speakers unable to understand English surveys cannot participate.

Inclusion Criteria

I have an upcoming appointment with my primary care doctor.

Patients have to be Kaiser Permanente members

Exclusion Criteria

I cannot complete surveys in English due to language barriers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants are randomized into Sleep VS or Usual Care pathways. Sleep VS participants complete a survey packet and may undergo further assessment based on results.

3 months

Every time patient completes the Sleep VS survey packet

Follow-up

Participants are monitored for response to treatment and identification of sleep disorders using Sleep VS and other questionnaires.

3 months

Regular follow-up visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• Sleep VS

Trial Overview The study is testing a new subjective method called Sleep Vital Sign (VS) to see if it helps better identify patients with sleep disorders in the primary care setting and track how well they respond to sleep therapy.

How Is the Trial Designed?

Group I: Sleep VS Experimental Treatment 1 Intervention

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."

Group II: Usual Care Active Control 1 Intervention

Patients 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.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Citations

1. sleep.biomedcentral.com sleep.biomedcentral.com/articles/10.1186/s41606-023-00085-1

Sleep as a vital sign - Sleep Science and Practice Sleep is causally linked to the maintenance of every major physiological body system and disturbed sleep contributes to myriad diseases.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK592970/

Sleep Disorders and Tools for Assessment - NCBI While these studies employ multiple tools, the gold standard for assessing sleep is the polysomnography (PSG), which includes electroencephalogram (EEG), ...

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2787642

Effectiveness of an Analytics-Based Intervention for ... The intervention group experienced 31% fewer vital sign checks per night with no change in the rates of intensive care unit transfer or code ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5102393/

Sleep as a vital sign: why medical practitioners need to ... The primary benefit of physicians routinely asking about sleep would be the detection and (hopefully) successful treatment of sleep disorders.

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1591448/full

Predicting sleep quality with digital biomarkers and artificial ... This study analyzed the relationship between sleep quality and vital sign data by conducting two experiments in 2023. The first experiment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7666176/

Let Sleeping Patients Lie, avoiding unnecessary overnight ... Sleep disruptions due to unnecessary overnight vital sign monitoring are associated with delirium, cognitive impairment, weakened immunity, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S088259632300180X

Understanding the effects of overnight vital signs ... Despite a lack of evidence regarding the efficacy of every 4 h vital signs, overnight vital signs monitoring is consistently the greatest disruptor to sleep for ...

8. pxjournal.org pxjournal.org/cgi/viewcontent.cgi?article=1185&context=journal

“Quiet at Night”: Reduced overnight vital sign monitoring ... “Quiet at Night”: Reduced overnight vital sign monitoring linked to both safety and improvements in patients' perception of hospital sleep quality. Patient ...