Health TrialsbyHealthPanel

Cognition After OSA Treatment Among Native American People (CATNAP)

ConditionsObstructive Sleep ApneaCognitive Change
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorWashington State University

About this trial

This research project will develop and implement a motivational interviewing and electronic messaging intervention to address obstructive sleep apnea (OSA), positive airway pressure (PAP) adherence, and risk of Alzheimer's disease and related dementias in American Indians. The project will work with American Indian Elders, aged 50 years and older, from three Northern Plains Reservations and surrounding communities. A total of 300 American Indian elders with a confirmed OSA diagnosis and prescribed PAP therapy will be randomized to receive usual care consisting of PAP therapy alone (control condition) or usual care plus the culturally informed CATNAP MI component (intervention condition).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 50 years and older

Self report American Indian or Alaskan Native

diagnosed with obstructive sleep apnea

prescribed PAP therapy and have a device

Disqualifiers

Living in a household with someone who is enrolled in the study

Already using PAP device at Medicaid recommended standards

Cognitive decline, unable to consent on their own

Trial design

Design model

Parallel

Treatments tested in this trial

  • CATNAP MI

    Behavioral

    Three motivational interviewing (MI) sessions will be facilitated by trained MI staff and will focus on improving participants' knowledge about their OSA diagnosis, understanding of sleep health, and increasing PAP use. Sessions will also provide information about health benefits associated with good sleep and will help participants create an action plan regarding their PAP use and indicators of success, when appropriate. Electronic messaging will be standardized for frequency and content but personalized to participants' preferred mode of delivery. Messages will focus on PAP adherence or non-adherence.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Waitlist Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Positive Airway Pressure (PAP) minutes per night

Participant mask-on time data collected by the PAP equipment will be extracted as continuous minutes per night.

Time frame
9 months
2

Nights of PAP use

Proportion of nights with 4+ hours of PAP use from PAP device

Time frame
9 months
3

PAP adherence

Use of device for more than 240 minutes per night, on 21 or more days out of the past 30 days. From PAP device.

Time frame
9-months

Secondary outcomes

1

Montreal Cognitive Assessment total score

The Montreal Cognitive Assessment is a widely used self-report instrument to screen for cognitive impairment and probable dementia. It comprises 30 items and takes approximately 10 minutes to complete. The assessment generates a summary score with range of 0 to 30, with scores 25 and above indicating normal cognition. Scores of 19-25 are considered to indicate mild cognitive impairment, scores of 11-21 indicate probable dementia, and scores less than 10 indicating severe cognitive impairment and Alzheimer's disease.

Time frame
9 months
2

Cognivue total score

The Cognivue Clarity device (Clarity: Comprehensive 10-Minute Cognitive Self Test \| Cognivue®) is a 10- to 15-minute patient-administered test that evaluates cognition in 6 domains: visuospatial, executive function, memory, naming/language, delayed recall, and abstraction. Study staff will be present to provide assistance in using the device, as needed. The device generates a summary score with scores 75 and above indicating normal cognitive function, 50-75 indicating mild cognitive impairment, and scores below 50 indicating severe cognitive impairment.

Time frame
9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington State University

Lead sponsor

Missouri Breaks Industries Research, Inc.

Collaborator

University of Washington

Collaborator

University of Minnesota

Collaborator

Source ClinicalTrials.gov
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