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AzTrials

SleepNCT04323254

Language of Sleepiness

An observational study of Sleep and Sleep Disorder, run by University of California, San Diego at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Sleep, Sleep Disorder, Sleepiness
How many people
200 participants
Where
2 sitesUnited States
Study dates
23 Mar 2020to 23 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • Total participants: 200 (UCSD only)
  • Ages: 18 - 89
  • Gender: Men and Women
  • Ethnic background: All
  • We will not recruit vulnerable patient groups.

Who cannot join

  • Prior Sleep consultation
  • Prisoners
  • Cognitive impairment, unable to provide consent, or unable to carry out research procedures

Trial locations and contacts

2 sites in 1 country.

Pamela DeYoung, RPSGT contact

8582462183

pdeyoung@health.ucsd.edu

United States2 sites, 2 recruiting

  • UCSD Health - Pulmonary and Sleep Clinic

    La Jolla, California, 92121

    Pamela DeYoung, RPSGT, 858-246-2183, pdeyoung@health.ucsd.edu

    Not yet recruiting

  • Altman Clinical and Translational Research Institute

    San Diego, California, 92093-0990

    Pam Deyoung, 858-246-2183

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Medical subject headings
Sleep Wake Disorders, Sleepiness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 5 minutes

Secondary outcomes (4)

  1. 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).

    Measured: 5 minutes

  2. 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.

    Measured: 5 minutes

  3. 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).

    Measured: 5 minutes

  4. 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.

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2020
  2. Study start23 Mar 2020
  3. Primary completion23 Mar 2021 (estimated)
  4. Study completion23 Mar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04323254
Sponsor's protocol ID
190489
Status last verified
Nov 2020
First submitted
24 Mar 2020
Last updated
5 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23910433

  • 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.

    PubMed 23589584

  • 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.

    PubMed 25682233

  • 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.

    PubMed 25940253

  • 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.

    PubMed 17580592

  • 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.

    PubMed 23088593

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep and Sleep Disorder, run by University of California, San Diego at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pamela DeYoung, RPSGT (8582462183, pdeyoung@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Language of Sleepiness Questionniare (time frame: 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04323254, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.

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