Language of Sleepiness

Sleep Clinical Trial

Official title:

The Language of Sleepiness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04323254
• Other study ID #: 190489
• Status: Recruiting
• Start date: March 23, 2020
• Est. completion date: March 23, 2021

Study information

• Verified date: November 2020
• Source: University of California, San Diego
• Contact: Pamela DeYoung, RPSGT
• Phone: 8582462183
• Email: pdeyoung[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 23, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep
• Sleep Disorder
• Sleep Wake Disorders
• Sleepiness

Locations

Country	Name	City	State
United States	UCSD Health - Pulmonary and Sleep Clinic	La Jolla	California
United States	Altman Clinical and Translational Research Institute	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (6)

Daurat A, Ricarrère 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Language of Sleepiness Questionniare	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	Work Productivity Impairement Questionnaire	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
Secondary	San Diego Wisdom Scale (SD-WISE)	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
Secondary	Functional Outcomes of Sleep Questionnaire	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
Secondary	Beck Depression Index II	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