Recruiting

Cognition After OSA

Sponsor:

Washington State University

Code:

NCT06227572

Conditions

Obstructive Sleep Apnea

Cognitive Change

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

CATNAP MI

Study Details

Brief summary:

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).

Conditions

Obstructive Sleep Apnea

Cognitive Change

Study ID

NCT06227572

Start date

Feb 6, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

The CATNAP MI intervention consists of 3 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 electronic messaging to support PAP adherence, and usual care. Data will be collected at baseline, 3-months, and 9-months.

no intervention: Waitlist Control Group

Usual care, consisting of an in-service on how to operate the PAP machine, and a mask fitting to select the most comfortable, effective mask for the individual. After 4-6 weeks of use, the participant will be contacted by Missouri Breaks Durable Medical Equipment to review objective adherence data and address any challenges or barriers to therapy such as treatment-emergent central apneas. Data will be collected at baseline, 3-months, and 9-months.

Interventions

CATNAP MI

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 outcome measure

  • Positive Airway Pressure (PAP) minutes per night [ Time Frame: 9 months ]
  • Nights of PAP use [ Time Frame: 9 months ]
  • PAP adherence [ Time Frame: 9-months ]

Central Contacts and Locations

Central contacts

Denise Dillard, PhD

206-708-8633denise.dillard@wsu.edu

Madison B Ramos, BA

madison.ramos@wsu.edu

Locations

Missouri Breaks Industries Research Inc

Recruiting

Eagle Butte, South Dakota, United States, 57625

Contacts

Marcia O'Leary, RN

(605) 964-1260marcia.oleary@mbiri.com

Principal Investigator:

Marcia O'Leary, RN

More Information

Sponsor

Washington State University

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Washington State University on 2026-01-09.