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Language of Sleepiness

NCT ID: NCT04323254

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-23

Study Completion Date

2021-03-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep Sleep Disorder Sleepiness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jazz Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Bernie.Sunwoo

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernie Sunwoo, MBBS

Role: PRINCIPAL_INVESTIGATOR

Faculty

Locations

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UCSD Health - Pulmonary and Sleep Clinic

La Jolla, California, United States

Site Status NOT_YET_RECRUITING

Altman Clinical and Translational Research Institute

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pamela DeYoung, RPSGT

Role: CONTACT

[email protected]
8582462183

Facility Contacts

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Pamela DeYoung, RPSGT

Role: primary

[email protected]
858-246-2183

Pam Deyoung

Role: primary

858-246-2183

References

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Jordan AS, McSharry DG, Malhotra A. Adult obstructive sleep apnoea. Lancet. 2014 Feb 22;383(9918):736-47. doi: 10.1016/S0140-6736(13)60734-5. Epub 2013 Aug 2.

Reference Type BACKGROUND
PMID: 23910433 (View on PubMed)

Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.

Reference Type BACKGROUND
PMID: 23589584 (View on PubMed)

Heinzer R, Vat S, Marques-Vidal P, Marti-Soler H, Andries D, Tobback N, Mooser V, Preisig M, Malhotra A, Waeber G, Vollenweider P, Tafti M, Haba-Rubio J. Prevalence of sleep-disordered breathing in the general population: the HypnoLaus study. Lancet Respir Med. 2015 Apr;3(4):310-8. doi: 10.1016/S2213-2600(15)00043-0. Epub 2015 Feb 12.

Reference Type BACKGROUND
PMID: 25682233 (View on PubMed)

Hirsch Allen AJM, Bansback N, Ayas NT. The effect of OSA on work disability and work-related injuries. Chest. 2015 May;147(5):1422-1428. doi: 10.1378/chest.14-1949.

Reference Type BACKGROUND
PMID: 25940253 (View on PubMed)

Weaver TE, Maislin G, Dinges DF, Bloxham T, George CF, Greenberg H, Kader G, Mahowald M, Younger J, Pack AI. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007 Jun;30(6):711-9. doi: 10.1093/sleep/30.6.711.

Reference Type BACKGROUND
PMID: 17580592 (View on PubMed)

Daurat A, Ricarrere M, Tiberge M. Decision making is affected in obstructive sleep apnoea syndrome. J Neuropsychol. 2013 Mar;7(1):139-44. doi: 10.1111/j.1748-6653.2012.02039.x. Epub 2012 Oct 23.

Reference Type BACKGROUND
PMID: 23088593 (View on PubMed)

Other Identifiers

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190489

Identifier Type: -

Identifier Source: org_study_id