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NCT Number: NCT06227572

Cognition After OSA Treatment Among Native American People (CATNAP)

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).

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Key information

Conditions

Obstructive Sleep Apnea Apnea Cognitive Change Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Missouri Breaks Industries Research Inc

Eagle Butte, South Dakota, 57625, United States

Location status: Recruiting

Location contact

Marcia O'Leary, RN

CONTACT

[email protected]

(605) 964-1260

Marcia O'Leary, RN

PRINCIPAL_INVESTIGATOR

About this study

The investigators will develop a multilevel 9-month culturally informed motivational interviewing and electronic messaging intervention- "Cognition After Obstructive Sleep Apnea (OSA) Among Native American People" (CATNAP) to: 1) provide participants with Motivational Interviewing sessions to address obstructive sleep apnea (OSA), positive airway pressure (PAP) adherence, and risk of Alzheimer's disease and related dementias (ADRD) in American Indians and 2) provide participants with electronic messaging to support PAP adherence among American Indian elders, aged 50 years and older.

This study will explore the relationship between OSA and cognitive function and evaluate OSA as a mechanism for the strong association between sleep disorders and Alzheimer's disease and related dementias (ADRD). CATNAP will be implemented as a randomized controlled trial at 4 community sites serving American Indians in the Northern Plains. A total of 300 American Indian elders, aged 50 years and older, 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 component (intervention condition).

The primary outcome is PAP adherence and secondary outcome cognitive function. The study will partner with Missouri Breaks Industries Research Inc., and Missouri Breaks Durable Medical Equipment to monitor participants PAP use, which is uploaded automatically to the cloud. Outcomes will be measured at baseline, 3-months, and 9-months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 50 years and older
  • Self report American Indian or Alaskan Native
  • diagnosed with obstructive sleep apnea
  • prescribed PAP therapy and have a device
  • *Ability to understand written and spoken English; and
  • *Ability and willingness to follow all study protocols.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Positive Airway Pressure (PAP) minutes per night

    Time frame: 9 months

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

  2. Nights of PAP use

    Time frame: 9 months

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

  3. PAP adherence

    Time frame: 9-months

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

Secondary outcomes

  1. Montreal Cognitive Assessment total score

    Time frame: 9 months

    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.

  2. Cognivue total score

    Time frame: 9 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Denise Dillard, PhD

CONTACT

[email protected]

206-708-8633

Madison B Ramos, BA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Collaborators

  • Missouri Breaks Industries Research, Inc.
  • University of Minnesota
  • University of Washington

Registry information

Official study title

Cognition After Obstructive Sleep Apnea (OSA) Treatment Among Native American People (CATNAP)

Acronym: CATNAP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2024
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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