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Validating the Use of a Subjectively Reported Sleep Vital Sign

NCT03018912 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2022-07-06

No results posted yet for this study

Summary

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.

Conditions

  • Obstructive Sleep Apnea (OSA)
  • Insomnia
  • Restless Leg Syndrome (RLS)
  • Hypersomnia Type; Sleep Disorder
  • Shift Work Sleep Disorders

Interventions

OTHER

Sleep VS

During check in patients are instructed to complete the Sleep VS survey packet only. The Sleep VS survey packet will take approximately 4 minutes to complete. The packet includes the subjective Sleep VS and additional sleep questionnaires, such as ESS, FOSQ-10, ISI, and sleep-wake pattern questions. The subjective Sleep VS is composed of the following 2 questions: 1. How many days a week are you satisfied with your sleep? 2. How many days a week is sleepiness a problem?

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Dennis Hwang, MD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2019-06-01
Completion
2025-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03018912 on ClinicalTrials.gov