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Language of Sleepiness

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ClinicalTrials.gov Identifier: NCT04323254
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : November 5, 2020
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Bernie.Sunwoo, University of California, San Diego

Brief 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.

Condition or disease
Sleep Sleep Disorder Sleepiness

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Language of Sleepiness
Actual Study Start Date : March 23, 2020
Estimated Primary Completion Date : March 23, 2021
Estimated Study Completion Date : March 23, 2021



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients new to the UCSD Pulmonary and Sleep Clinic with no prior sleep consultations.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323254


Contacts
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Contact: Pamela DeYoung, RPSGT 8582462183 pdeyoung@health.ucsd.edu

Locations
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United States, California
UCSD Health - Pulmonary and Sleep Clinic Not yet recruiting
La Jolla, California, United States, 92121
Contact: Pamela DeYoung, RPSGT    858-246-2183    pdeyoung@health.ucsd.edu   
Altman Clinical and Translational Research Institute Recruiting
San Diego, California, United States, 92093-0990
Contact: Pam Deyoung    858-246-2183      
Sponsors and Collaborators
University of California, San Diego
Jazz Pharmaceuticals
Investigators
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Principal Investigator: Bernie Sunwoo, MBBS Faculty
Publications:
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Responsible Party: Bernie.Sunwoo, Associate Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04323254    
Other Study ID Numbers: 190489
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleepiness
Nervous System Diseases
Neurologic Manifestations
Mental Disorders