NCT03138993

Brief Summary

This study evaluates the feasibility of conducting a randomized controlled trial that tests a patient decision aid for obstructive sleep apnea in older adults with newly-diagnosed obstructive sleep apnea treated in an outpatient sleep clinic. Half of the participants will use a patient decision aid, while the other half will receive general information about sleep.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 14, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

February 14, 2017

Last Update Submit

September 24, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Recruitment rates

    The investigators will measure recruitment rates for our recruitment strategies

    Through study completion, an average of 1 year

  • Enrollment rates

    The investigators will measure enrollment rates

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • The length of time for completing the intervention session

    Through study completion, an average of 1 year

Study Arms (2)

Patient decision aid

ACTIVE COMPARATOR
Behavioral: Patient decision aid

General sleep education

SHAM COMPARATOR
Behavioral: General sleep education

Interventions

Web-based patient decision aid plus a paper workbook.

Patient decision aid

Web-based information about sleep plus a paper workbook

General sleep education

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>= 60 years
  • diagnosed with obstructive sleep apnea on a sleep study
  • able to read English-language newspaper text (if needed, using contact lens/glasses)
  • able to write words in a paper booklet
  • scheduled for a sleep clinic appointment with a UCLA sleep provider
  • able to attend a sleep educational session prior to sleep clinic appointment

You may not qualify if:

  • unable to provide informed consent
  • dementia
  • mild cognitive impairment diagnosis or Mini-Cog score \< 3
  • treated for obstructive sleep apnea for \> 30 days prior to scheduled sleep education intervention
  • severe physical or mental illness (e.g., hospitalized within past 7 days prior to scheduled sleep education intervention, substance abuse within 90 days of sleep education intervention)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • Fung CH, Martin JL, Liang LJ, Hays RD, Col N, Patterson ES, Josephson K, Mitchell MN, Sanchez MC, Aysola R, Song Y, Dzierzewski JM, Huang D, Zeidler M, Alessi C. Efficacy of a patient decision aid for improving person-centered decision-making by older adults with obstructive sleep apnea. J Clin Sleep Med. 2021 Feb 1;17(2):121-128. doi: 10.5664/jcsm.8798.

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
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2017

First Posted

May 3, 2017

Study Start

May 22, 2017

Primary Completion

May 29, 2018

Study Completion

November 30, 2018

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations