NCT03262519

Brief Summary

Obstructive sleep apnea (OSA) is an extremely common disease with inadequately explored neurocognitive consequences. The investigators will study OSA patients before and after treatment to understand how OSA changes decision making abilities, and whether treatment can reverse such cognitive changes. These results could provide deeper insight into how OSA affects decision making either temporarily or permanently, and provide another rationale or motivation for treatment of OSA in adults.

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
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 7, 2022

Status Verified

March 1, 2022

Enrollment Period

1.8 years

First QC Date

July 25, 2017

Last Update Submit

March 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Iowa Gambling Task

    The Iowa Gambling Task is a psychological task thought to simulate real-life decision making. It is completed on a computer and takes about 10 minutes. It is widely used in research on cognition.

    2 months (baseline, 2 months later)

Secondary Outcomes (4)

  • Change in Cognitive Reflection Test (CRT)

    2 months (baseline, 2 months later)

  • Change in Intertemporal Choice

    2 months (baseline, 2 months later)

  • Change in Balloon Analogue Risk Task (BART)

    2 months (baseline, 2 months later)

  • Change in Epworth Sleepiness Score

    2 months (baseline, 2 months later)

Study Arms (1)

Patients at UCSD Sleep Medicine Clinic

Patients referred for sleep testing (either home sleep testing or in-lab full polysomnography) will be approached for participation.

Diagnostic Test: Computer based neurocognitive testing

Interventions

Iowa Gambling Task, The Balloon Task, Intertemporal choices task, Cognitive Reflection Test, Physiological and self-reported measures of OSA/sleep related symptoms, General health and physiological measures.

Patients at UCSD Sleep Medicine Clinic

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects aged 18-75 referred to the UCSD Sleep clinic for either home or in-laboratory testing will be considered for inclusion in the study.

You may qualify if:

  • participants will be enrolled at the UCSD Sleep Clinic at Chancellor Park.
  • Ages 18-75
  • Gender: Men and woman
  • Ethnic background: All
  • Health Status: to the UCSD Sleep clinic for either home or in-laboratory testing

You may not qualify if:

  • Ongoing CPAP treatment for OSA
  • Inability to use a tablet device (e.g. no reading glasses, or unfamiliar with devices).
  • Severe cardiopulmonary disorder that requires treatment with supplemental oxygen therapy.
  • Inability to speak English fluently, as some of the questionnaires/tests are only validated in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 25, 2017

Study Start

July 20, 2017

Primary Completion

May 1, 2019

Study Completion

December 1, 2022

Last Updated

March 7, 2022

Record last verified: 2022-03

Locations