Validating the Use of a Subjectively Reported Sleep Vital Sign

NCT03018912 | Unknown

• 1 other identifier: KPSleep-002
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Subjective Sleep Vital Sign (VS); Primary Care; Sleep Medicine; Cognitive Behavioral Therapy (CBT); Obstructive Sleep Apnea (OSA); Insomnia; Complex Sleep Disorders; Predictive Analytics; Screening; Therapy Outcomes

Outcome Measures

Primary Outcomes (1)

• Sleep Disorder Identification Rates

  Compare the rate of identification of sleep disorders between each pathway

  3 months

Secondary Outcomes (4)

• Referral Rates

  3 months

• Sleep VS vs Sleep Questionnaires

  Every time patient completes the Sleep VS survey packet over a 3 month period.

• Assessing response to treatment using Sleep VS

  Every time patient completes the Sleep VS survey packet over a 3 month period.

• Medications and Encounters

  3 months

Study Arms (2)

Sleep VS

EXPERIMENTAL

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."

Other: Sleep VS

Usual Care

NO 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.

Interventions

Sleep VS OTHER

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?

Sleep VS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that have a scheduled office visit with their primary care physician.
• Patients have to be Kaiser Permanente members

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Sleep Center; Fontana Medical Center, Kaiser Permanente

Fontana, California, 92335, United States

Location

Related Publications (1)

• Institute of Medicine (US) Committee on Sleep Medicine and Research; Colten HR, Altevogt BM, editors. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Washington (DC): National Academies Press (US); 2006. Available from http://www.ncbi.nlm.nih.gov/books/NBK19960/

  PMID: 20669438 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Restless Legs Syndrome; Disorders of Excessive Somnolence; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Parasomnias; Chronobiology Disorders; Occupational Diseases

Study Officials

• Dennis Hwang, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Medical Director

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: January 12, 2017
• Study Start: October 22, 2018
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2025
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)