Summary

Eligibility
for people ages 18-89 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
Robert L. Owens
Photo of Robert L. Owens
Robert L. Owens

Description

Summary

Subjects will complete an electronic consent form and then fill out questionnaires on a tablet computer. The answers to the questions will be recorded to a secure electronic database, along with the results of a clinical overnight sleep study performed separately from this research study (this research study will not perform any overnight visits). After the overnight study diagnosis researchers will see which answers are most commonly given in association with each diagnosis. In addition, we will assess to what extent the sleep disorder impacts the patient's perception of his/her quality of life.

Official Title

The Language of Sleepiness

Details

Research questionnaires will be given along with the clinical intake form to all patients who are interested in participating in our study. Subjects will complete an electronic consent form and then proceed to questionnaires on a tablet computer (outlined below). The answers to the questions will be recorded to a secure electronic database, REDCap, along with the results of the overnight sleep study (when available). For the initial analysis, we will determine the sleep diagnosis and see which descriptors are most commonly used in association with each diagnosis. In addition, we will assess to what extent the sleep disorder impacts the patient's perception of his/her quality of life. These analyses will be simple correlations for the linear scales and unpaired t-tests to compare different diagnoses.

REDCap REDCap, is a password-protected secure web application that we will use to build and manage our study database. REDCap is a HIPAA-compliant environment. Subjects will have a coded study identifier associated with their research documents and questionnaires. Only key personnel on this study will have access to the study database.

Questionnaires:

  • Work Productivity Impairement Questionnaire-The questionnaire assesses how much sleepiness has impacted the subject's ability to work.
  • Language of Sleepiness Questionniare-The questionnaire will capture what descriptors those with sleep issues use prior to their sleep consulation.
  • San Diego Wisdom Scale (SD-WISE) - The questionnaire assesses subject's wisdom scores.
  • Functional Outcomes of Sleep Questionnaire - The questionnaire is a subjective measure of sleepiness and quality of life.
  • Beck Depression Index II - The questionnaire assesses mental health (i.e. depression).

Study Visit Patients that elect to participate in the study will be consented in either the sleep clinic conference room or sleep clinic exam room. Subjects will then complete the questionnaires on a tablet. The research documents and questionnaires will be hosted on REDCap, a secure electronic database. For participants who are not comfortable with the electronic format, we will provide paper copies of the questionnaires and enter their data manually into REDCap.

The total study time is estimated to be <20 minutes, which includes the consent process. Administration of the questionnaires should take 5-7 minutes. These activities will be completed before the subject's sleep consultation.

After Study Visit:

We will access subjects' medical records to document their vitals, age, race/ethnicity, height, weight, date of birth, phone number, medications, medical and surgical history, alcohol history, illicit drug including cannabidiol, allergies, and Epworth Sleepiness Scale (ESS) value from the day of their study visit (i.e. first sleep consultation appointment). We will also collect data from their sleep study. If the subject completes a Home Sleep Test the following will be obtained: time to bed, wake time, apnea hypopnea index (AHI), apnea index (AI), hypopnea index (HI), obstructive apnea index (OAI), central apnea index (CAI), mixed apnea index (MAI), Cheyne - Stokes respiration, oxygen desaturation index (ODI), oxygen saturation, # of breaths, and pulse.

Keywords

Sleep Sleep Disorder Sleepiness Sleep Wake Disorders

Eligibility

You can join if…

Open to people ages 18-89

  1. Total participants: 200 (UCSD only)
  2. Ages: 18 - 89
  3. Gender: Men and Women
  4. Ethnic background: All

We will not recruit vulnerable patient groups.

You CAN'T join if...

  1. Prior Sleep consultation
  2. Prisoners
  3. Cognitive impairment, unable to provide consent, or unable to carry out research procedures

Locations

  • UCSD Health - Pulmonary and Sleep Clinic
    La Jolla California 92121 United States
  • Altman Clinical and Translational Research Institute
    San Diego California 92093-0990 United States

Lead Scientist at UCSD

  • Robert L. Owens
    Associate Professor, Medicine. Authored (or co-authored) 101 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04323254
Study Type
Observational
Last Updated