CATNAP MI for Obstructive Sleep Apnea

(CATNAP Trial)

Overseen By Madison B Ramos, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington State University

Disqualifiers: Living with participant, Cognitive decline, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 9 months

140 Participants Needed

Trial Summary

What is the purpose of 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).

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment CATNAP MI for obstructive sleep apnea?

Research shows that treatments like continuous positive airway pressure (CPAP) can significantly reduce symptoms of obstructive sleep apnea, such as sleepiness and breathing interruptions during sleep. While CATNAP MI is not directly mentioned, similar treatments have been effective in managing sleep apnea symptoms. ^{1 2 3 4 5}

Is CATNAP MI safe for humans?

There is no specific safety data available for CATNAP MI in the provided research articles. ^{6 7 8 9 10}

Eligibility Criteria

The CATNAP study is for American Indian Elders aged 50 or older with obstructive sleep apnea (OSA) who are already using PAP therapy. Participants must be able to understand English and follow the study's procedures.

Inclusion Criteria

I am 50 years old or older.

I use a PAP device for my sleep therapy.

I am willing and able to follow all study procedures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive usual care with PAP therapy or usual care plus the CATNAP MI intervention, including Motivational Interviewing sessions and electronic messaging to support PAP adherence

9 months

Data collected at baseline, 3-months, and 9-months

Follow-up

Participants are monitored for PAP adherence and cognitive function outcomes

4 weeks

Treatment Details

Interventions

• CATNAP MI

Trial Overview This trial tests a new approach called CATNAP MI, which combines motivational interviewing and electronic messaging, aiming to improve OSA treatment adherence and reduce Alzheimer's risk among Native American elders.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

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.

Group II: Waitlist Control Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

Missouri Breaks Industries Research, Inc.

Collaborator

Trials

8

Recruited

2,100+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Findings from Research

Treatment for obstructive sleep apnea significantly reduces daytime sleepiness, which is a common symptom of the condition.

The study suggests that while daytime sleepiness improves, further research is needed to determine if treatment also enhances other health outcomes related to obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of OSA: What (else) can it accomplish? Sorsby, SC., Kraleti, S., Jarrett, D.[2020]

In a study of 14 subjects with mild to moderate obstructive sleep apnea (OSA), using a shoulder-head elevation pillow (SHEP) resulted in a mean apnea-hypopnea index (AHI) reduction from 27 to 21, but was less effective than nasal continuous positive airway pressure (nCPAP), which achieved a mean AHI of 5.

While four subjects achieved treatment success with SHEP, nCPAP was successful in 12 subjects, indicating that elevated posture may serve as a second-line therapy for OSA, but it is not as effective as nCPAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elevated posture for the management of obstructive sleep apnea. Skinner, MA., Kingshott, RN., Jones, DR., et al.[2018]

In a study of 53 patients with obstructive sleep apnea (OSA), treatment with a simple continuous positive airway pressure (CPAP) device significantly reduced the apnea hypopnea index (AHI), arousal index (ArI), and oxygen desaturation index (ODI), indicating effective management of OSA symptoms.

The efficacy of the simple CPAP was comparable to traditional CPAP, with no significant differences in residual AHI, ArI, or ODI, suggesting that the simpler device can effectively replace traditional CPAP without compromising treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of simple continuous positive airway pressure on patients with obstructive sleep apnea]. Qiu, ZH., Wei, QS., Wu, YX., et al.[2019]

In a study of 102 adults with obstructive sleep apnea (OSA) followed for about 48 months, long-term use of CPAP did not lead to significant overall changes in apnea-hypopnea index (AHI) or oxygen desaturation index (ODI), indicating limited efficacy across the board.

However, CPAP treatment showed beneficial effects in specific subgroups, improving AHI in patients with moderate OSA and increasing nadir oxygen saturation in those with severe OSA, suggesting that CPAP may be more effective depending on the severity of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The changes of AHI after long-term CPAP in patients with comorbid OSA and cardiovascular disease. Cheng, Y., Ou, Q., Chen, B., et al.[2023]

In a study of 391 patients with minimally symptomatic obstructive sleep apnoea, CPAP therapy significantly reduced daytime sleepiness and improved self-assessed health status after 6 months of treatment.

However, CPAP did not show any improvement in the predicted 5-year vascular risk or its individual components, suggesting that while it helps with sleepiness, it may not affect long-term cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure improves sleepiness but not calculated vascular risk in patients with minimally symptomatic obstructive sleep apnoea: the MOSAIC randomised controlled trial. Craig, SE., Kohler, M., Nicoll, D., et al.[2022]

In a study of 41 non-diabetic patients who had a ST-segment elevation myocardial infarction, those with more severe obstructive sleep apnea (higher apnea-hypopnea index) were more likely to experience major adverse cardiac events over a 5-year follow-up.

The apnea-hypopnea index was identified as an independent predictor of these adverse events, suggesting that monitoring and managing obstructive sleep apnea could be important for improving cardiac outcomes in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between severity of obstructive sleep apnea and adverse cardiac outcomes in non-diabetic patients presenting with myocardial infarction. Zhao, LP., Loh, K., Loo, G., et al.[2018]

In a study of 105 patients with obstructive sleep apnoea (OSA) who experienced an acute myocardial infarction (AMI), 18.4% developed major adverse cardiac events (MACE) over a 5-year follow-up, primarily linked to non-culprit lesions rather than the initial culprit lesion.

Among the 18 patients who experienced MACE, 12 had reinfarctions and 6 required repeat revascularization, indicating that OSA may contribute significantly to the progression of coronary artery disease beyond the immediate effects of the initial heart attack.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culprit versus non-culprit lesion related adverse cardiac events in patients with obstructive sleep apnoea. Li, R., Loh, K., Loo, G., et al.[2020]

In a study of 1860 Chinese subjects with obstructive sleep apnea (OSA) followed for an average of 8.3 years, the time spent with oxygen saturation below 90% (TST90) was found to be a significant predictor of major adverse cardiovascular events (MACEs), while the apnea-hypopnea index (AHI) was not.

Among a subgroup of 333 patients with moderate to severe OSA who were younger and more obese, regular CPAP treatment was associated with a reduced risk of MACEs, highlighting that certain clinical phenotypes may benefit more from CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular outcomes in obstructive sleep apnoea and implications of clinical phenotyping on effect of CPAP treatment. Xu, PH., Fong, DYT., Lui, MMS., et al.[2023]

In a study of 502 patients over one year, 1-2% experienced serious complications from CPAP and BIPAP treatments for sleep-related breathing disorders, including long central apneas and severe hypoxemia.

Mask leakages and central apneas were common issues that could lead to ineffective therapy, highlighting the need for initial treatment to be conducted in controlled sleep laboratory settings to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Errors and risks in administration of nasal respiratory therapy of obstructive sleep apnea]. Stammnitz, A., Becker, H., Schneider, H., et al.[2016]

Obstructive sleep apnea (OSA) affects about 9% of middle-aged men and 4% of women, with higher prevalence in specific groups like the elderly and those with heart conditions, highlighting its widespread impact on health.

OSA and insufficient sleep duration can lead to serious health issues, including cardiovascular disease, impaired cognitive function, and increased risk of accidents, emphasizing the importance of addressing sleep disorders for overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology, risk factors, and consequences of obstructive sleep apnea and short sleep duration. Al Lawati, NM., Patel, SR., Ayas, NT.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of OSA: What (else) can it accomplish? [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Elevated posture for the management of obstructive sleep apnea. [2018]

3. China pubmed.ncbi.nlm.nih.gov

[Efficacy of simple continuous positive airway pressure on patients with obstructive sleep apnea]. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

The changes of AHI after long-term CPAP in patients with comorbid OSA and cardiovascular disease. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure improves sleepiness but not calculated vascular risk in patients with minimally symptomatic obstructive sleep apnoea: the MOSAIC randomised controlled trial. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Relationship between severity of obstructive sleep apnea and adverse cardiac outcomes in non-diabetic patients presenting with myocardial infarction. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Culprit versus non-culprit lesion related adverse cardiac events in patients with obstructive sleep apnoea. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Cardiovascular outcomes in obstructive sleep apnoea and implications of clinical phenotyping on effect of CPAP treatment. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

[Errors and risks in administration of nasal respiratory therapy of obstructive sleep apnea]. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Epidemiology, risk factors, and consequences of obstructive sleep apnea and short sleep duration. [2022]