Language of Sleepiness

November 3, 2020 updated by: Bernie.Sunwoo, University of California, San Diego

The Language of Sleepiness

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92121
        • Not yet recruiting
        • UCSD Health - Pulmonary and Sleep Clinic
      • San Diego, California, United States, 92093-0990
        • Recruiting
        • Altman Clinical and Translational Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients new to the UCSD Pulmonary and Sleep Clinic with no prior sleep consultations.

Description

Inclusion Criteria:

  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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Language of Sleepiness Questionniare
Time Frame: 5 minutes
The questionnaire will capture what descriptors those with sleep issues use prior to their sleep consulation. Subjects will choose the best descriptors of their sleeping problem and rank the top five of them in order (under the word Rank in the Table). For the top three descriptors that they chose, they will rank them on a scale of 1-10 in severity (1= minor problem, 10=major problem).
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work Productivity Impairement Questionnaire
Time Frame: 5 minutes
The questionnaire assesses how much sleepiness has impacted the subject's ability to work. Subject will report how many hours they work and how many of those hours are affected by sleepiness. Subjects will then be asked about how much sleepiness or tiredness affected their productivity while working by ranking at which percentage of their usual productivity were they working in the last 30 days despite sleepiness/tiredness (0% = completely unable to perform work, 100% = Productivity not at all affected).
5 minutes
San Diego Wisdom Scale (SD-WISE)
Time Frame: 5 minutes
The questionnaire assesses subject's wisdom scores on a scale of 1-5 within 6 categories: Decisiveness, Emotional Regulation, Self-Reflection, Pro-Social Behaviors, and Social Advising. Higher scores indicate higher levels of wisdom in each respective category.
5 minutes
Functional Outcomes of Sleep Questionnaire
Time Frame: 5 minutes
The questionnaire is a subjective measure of sleepiness and quality of life. The score range is 0-28 points, with higher scores indicating greater insomnia severity. The suggested guidelines for score interpretation is 0 -7 for no clinically significant insomnia, 8-14 for subthreshold insomnia, 15-21 for clinical insomnia (moderate severity), and 22-28 for clinical insomnia (severe).
5 minutes
Beck Depression Index II
Time Frame: 5 minutes
The questionnaire assesses mental health (i.e. depression). Each of the 21 items are given weighted values corresponding to a symptom of depression and summed to give a single score. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Jazz Pharmaceuticals

Investigators

  • Principal Investigator: Bernie Sunwoo, MBBS, Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 23, 2020

Primary Completion (ANTICIPATED)

March 23, 2021

Study Completion (ANTICIPATED)

March 23, 2021

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (ACTUAL)

March 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190489

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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