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Sleep Vital Sign Assessment for Sleep Disorders (SSVS Trial)

N/A

Waitlist Available

Led By Dennis Hwang, MD

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Non-English speaking patients unable to understand English to complete the surveys

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a new sleep vital sign can help doctors recognize sleep disorders and track patients' responses to sleep therapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves only the use of a subjective reporting tool, there are no direct physical side effects associated with its use as it's not a medication or invasive procedure.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot complete surveys in English due to language barriers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sleep Disorder Identification Rates

Secondary study objectives

Assessing response to treatment using Sleep VS

Medications and Encounters

Referral Rates

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sleep VSExperimental Treatment1 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 CareActive Control1 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.

0 / 1Eligibility criteria met