NCT04323254

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2021

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

March 24, 2020

Last Update Submit

November 3, 2020

Conditions

SleepSleep DisorderSleepiness

Outcome Measures

Primary Outcomes (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).

    5 minutes

Secondary Outcomes (4)

  • Work Productivity Impairement Questionnaire

    5 minutes

  • San Diego Wisdom Scale (SD-WISE)

    5 minutes

  • Functional Outcomes of Sleep Questionnaire

    5 minutes

  • Beck Depression Index II

    5 minutes

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCSD Health - Pulmonary and Sleep Clinic

La Jolla, California, 92121, United States

NOT YET RECRUITING

Altman Clinical and Translational Research Institute

San Diego, California, 92093-0990, United States

RECRUITING

Related Publications (6)

  • 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.

    PMID: 23910433BACKGROUND

  • 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.

    PMID: 23589584BACKGROUND

  • 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.

    PMID: 25682233BACKGROUND

  • 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.

    PMID: 25940253BACKGROUND

  • 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.

    PMID: 17580592BACKGROUND

  • 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.

    PMID: 23088593BACKGROUND

MeSH Terms

Conditions

Sleep Wake DisordersSleepiness

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Bernie Sunwoo, MBBS

    Faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela DeYoung, RPSGT

CONTACT

8582462183pdeyoung@health.ucsd.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 26, 2020

Study Start

March 23, 2020

Primary Completion

March 23, 2021

Study Completion

March 23, 2021

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)