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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

SSVS Trial 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.Check my eligibility

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.See study design

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.

SSVS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sleep Disorder Identification Rates

Secondary outcome measures

Assessing response to treatment using Sleep VS

Medications and Encounters

Referral Rates

+1 more

SSVS 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Kaiser PermanenteLead Sponsor

538 Previous Clinical Trials

24,112,828 Total Patients Enrolled

3 Trials studying Insomnia

136,836 Patients Enrolled for Insomnia

Dennis Hwang, MDPrincipal InvestigatorKaiser Permanente

6 Previous Clinical Trials

3,098 Total Patients Enrolled

Media Library

Sleep VS Clinical Trial Eligibility Overview. Trial Name: NCT03018912 — N/A

Insomnia Research Study Groups: Sleep VS, Usual Care

Insomnia Clinical Trial 2023: Sleep VS Highlights & Side Effects. Trial Name: NCT03018912 — N/A

Sleep VS 2023 Treatment Timeline for Medical Study. Trial Name: NCT03018912 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room for participants in this trial?

"This trial, which was first posted on October 22nd 2018 and last updated on July 5th 2022, is not actively looking for participants. On the bright side, clinicaltrials.gov currently lists 1554 other studies that are recruiting patients."

Answered by AI