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

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Sleep disorders are commonly under-recognized in the primary care setting and available screening tools are often are limited. The study inestigators hypothesize that the use of a novel subjective sleep vital sign (VS) will improve recognition of patients with sleep disorders and can be utilized to track outcomes to sleep therapy.

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+