80 Participants Needed

Nuestro Sueno for Sleep Apnea

Recruiting at 1 trial location
KC
BB
SV
Overseen BySofia Vallejo
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Utah
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a couples-based program called Nuestro Sueno can improve sleep for Hispanic individuals with sleep apnea and their partners. The program aims to boost the use of positive airway pressure (PAP) devices and enhance sleep quality and overall life, including memory. Participants will either join telehealth sessions or receive information packets. Ideal participants are Hispanic individuals diagnosed with sleep apnea who are about to start using PAP for the first time or after a break, and who live with a romantic partner. Both partners should be comfortable with English or Spanish and have internet access for telehealth activities. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Nuestro Sueno intervention is safe for improving sleep health in Hispanic couples?

Research has shown that the Nuestro Sueno program is under study for its effects on sleep apnea. Although detailed information about the program's safety is limited, this trial is in an early stage. The primary goal is to assess the treatment's safety and comfort for participants. So far, no reports of serious side effects have emerged, suggesting it might be safe for participants.

The treatment includes online sessions with a community health worker, focusing on better communication, improving sleep quality, and using devices that aid breathing. Since this is not a medication, the risks may be lower compared to drug-based treatments. However, as with any clinical trial, staying informed and discussing any concerns with the study team or a doctor is important.12345

Why are researchers excited about this trial?

Researchers are excited about Nuestro Sueño for sleep apnea because it takes a unique couples-based approach. Unlike traditional treatments like CPAP machines, which focus solely on the patient's physical condition, Nuestro Sueño emphasizes improving communication and mutual support between partners. This trial uses telehealth sessions to enhance sleep quality and ensure better adherence to positive airway pressure therapy. By involving both partners in the treatment process, researchers hope to improve outcomes beyond what current methods achieve.

What evidence suggests that Nuestro Sueno might be an effective treatment for sleep apnea?

Research has shown that the Nuestro Sueno program, which participants in this trial may receive, could help people with sleep apnea use their breathing machines more regularly. In a study of 302 patients with sleep apnea, those who participated in a similar program adhered to their treatment more successfully. This suggests that Nuestro Sueno might help patients use their machines more consistently. Designed for Hispanic couples, the program focuses on improving communication and sleep quality, which could also enhance the partners' sleep. By improving sleep and machine use, the program may positively affect other areas of life, such as quality of life and memory.12678

Are You a Good Fit for This Trial?

This trial is for Latino couples over 35 years old where one partner has sleep apnea (OSA) and is starting or restarting positive airway pressure (PAP) treatment after a break of at least 3 months. Both must be able to read/write in English or Spanish, have internet access, and have been together for more than a year.

Inclusion Criteria

Patients inclusion criteria: 1) self-reported Latino ethnicity, 2) Age \>35, 3) Diagnosed with OSA (AHI\>10 or AHI\>5 with impairment) and intend to start PAP; 4) PAP naïve or-restarting CPAP after 3 months, 5) Married or cohabiting with a romantic partner for \>1 year; 6) Able to read/write English or Spanish, access to cellular (active data plan) or Wi-Fi, or able to use study devices in order to complete the telehealth intervention.
My partner can read/write in English or Spanish and wants to improve their sleep.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Couples attend 3 telehealth sessions with a community health worker for education and interventions to improve communication, sleep quality, and PAP use

1 month
3 telehealth sessions

Follow-up

Participants are monitored for sleep quality and PAP adherence over a 3-month period

3 months

Extension

Participants may continue to be monitored for long-term effects on sleep quality and Alzheimer's risk

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Nuestro Sueno
Trial Overview The study tests if 'Nuestro Sueno,' a culturally adapted intervention for couples, can improve PAP use and sleep quality among Hispanic partners with OSA. It compares this approach against basic information control to see if it also enhances life quality and memory.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Couples-based treatment- PatientExperimental Treatment1 Intervention
Group II: Couples-based treatment- PartnerExperimental Treatment1 Intervention
Group III: Information Control- PatientActive Control1 Intervention
Group IV: Information Control- PartnerActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

University of Arizona

Collaborator

Trials
545
Recruited
161,000+

Banner Health

Collaborator

Trials
26
Recruited
1,006,000+

Published Research Related to This Trial

In a clinical trial involving 302 patients with Obstructive Sleep Apnoea (OSA), the SLEEP-GOAL criterion demonstrated a higher success rate (69.8%) compared to the traditional Sher criteria (66.2%), suggesting it may provide a more comprehensive assessment of treatment outcomes.
The study revealed that relying solely on the Apnoea Hypopnea Index (AHI) can misclassify treatment success, as many patients showed significant improvements in blood pressure and oxygen levels that would not be captured by AHI alone.
SLEEP-GOAL: A multicenter success criteria outcome study on 302 obstructive sleep apnoea (OSA) patients.Pang, KP., Baptista, PM., Olszewska, E., et al.[2021]
In a study of 452 adult obstructive sleep apnea patients undergoing head and neck airway surgery, 89% of the surgeries were performed on an outpatient basis, which is contrary to existing guidelines.
The study found a zero catastrophic complication rate among ambulatory patients, indicating that such surgeries can be performed safely, although pain-related emergency room visits were common.
Safety of outpatient surgery for obstructive sleep apnea.Baugh, R., Burke, B., Fink, B., et al.[2013]

Citations

Providers' Perceived Disparities for Sleep Treatment in ...Despite the proven effectiveness of Positive Airway Pressure (PAP) therapy, treatment disparities persist, particularly among Spanish-speaking ...
Nuestro Sueno for Sleep ApneaIn a clinical trial involving 302 patients with Obstructive Sleep Apnoea (OSA), the SLEEP-GOAL criterion demonstrated a higher success rate (69.8%) compared to ...
Project DetailsThe outcomes will have important implications for identifying effective interventions to rescue brain injury, especially in obstructive sleep apnea patients ...
Cultural Adaptation of a Couples Intervention to Improve PAP ...Does Nuestro sueno improve the patient's positive airway pressure use over the first 3 months of using it compared to an information control?
Providers' Perceived Disparities for Sleep Treatment in ...Results: Spanish-speaking patients demonstrated significantly higher engagement across all measures compared to English-speaking patients: FIT test opt-in rates ...
Obstructive Sleep Apnea - StatPearls - NCBI BookshelfObstructive sleep apnea (OSA) is a sleep disorder characterized by repeated episodes of complete (apnea) or partial (hypopnea) collapse of the upper airway.
Obstructive sleep apnea and cardiovascular riskLos sujetos con apnea obstructiva del sueño (AOS) sufren episodios repetidos de obstrucción de la vía aérea superior durante el sueño, debido a su colapso ...
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