Nuestro Sueno for Sleep Apnea

Recruiting at 1 trial location

Overseen By Sofia Vallejo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Utah

Disqualifiers: Sleep disorders, Psychiatric disorders, Serious illness, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 month

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if the culturally adapted couples sleep health intervention (Nuestro Sueno) improves positive airway pressure use and sleep among Hispanic couples in which one partner was diagnosed with sleep apnea and starting positive airway pressure treatment. The main questions are: 1. Does Nuestro sueno improve the patient's positive airway pressure use over the first 3 months of using it compared to an information control? 2. Does Nuestro sueno improve sleep quality for both the patient and partner, compared to an information control? 3. Does Nuestro sueno improve other aspects of life including quality of life and memory, compared to an information control?

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 data supports the effectiveness of the treatment Nuestro Sueno for sleep apnea?

The research on selective upper airway stimulation (UAS) shows that it significantly reduces sleep apnea symptoms and improves sleepiness and oxygen levels in patients, suggesting that similar treatments like Nuestro Sueno might also be effective. ^{1 2 3 4 5}

Is the treatment Nuestro Sueno for sleep apnea generally safe for humans?

The safety of treatments for sleep apnea can vary. Some studies show that certain medications like benzodiazepines (a type of sedative) can increase the risk of serious breathing problems in people with sleep apnea. Additionally, patients with sleep apnea may face critical complications, including death, especially after surgery, if not properly monitored. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Couples-based treatment- Patient Experimental Treatment 1 Intervention

In this group, couples will attend 3-telehealth based sessions with a community health worker for education and interventions to improve communication, sleep quality and PAP use

Group II: Couples-based treatment- Partner Experimental Treatment 1 Intervention

In this group, couples will attend 3-telehealth based sessions with a community health worker for education and interventions to improve communication, sleep quality and PAP use

Group III: Information Control- Patient Active Control 1 Intervention

In this group, couples will recieve a standardized packet of insomnia about obstructive sleep apnea and starting positive airway pressure.

Group IV: Information Control- Partner Active Control 1 Intervention

In this group, couples will recieve a standardized packet of insomnia about obstructive sleep apnea and starting positive airway pressure.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of outpatient surgery for obstructive sleep apnea. Baugh, R., Burke, B., Fink, B., et al.[2013]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Selective upper airway stimulation for obstructive sleep apnea: a single center clinical experience. [2022]

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

Reliability and Validity of the Functional Outcomes of Sleep Questionnaire - Spanish Short Version (FOSQ-10SV) in Peruvian Patients With Obstructive Sleep Apnea. [2019]

3. Malaysia pubmed.ncbi.nlm.nih.gov

SLEEP-GOAL: A multicenter success criteria outcome study on 302 obstructive sleep apnoea (OSA) patients. [2021]

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

Patient-reported outcome: results of the multicenter German post-market study. [2020]

5. Spain pubmed.ncbi.nlm.nih.gov

[Effect on quality of life of nCPAP treatment in patients with obstructive sleep apnea]. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Safety of outpatient surgery for obstructive sleep apnea. [2013]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Benzodiazepines Associated With Acute Respiratory Failure in Patients With Obstructive Sleep Apnea. [2020]

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

Respiratory Sensing Lead Malfunction in Upper Airway Stimulation: A Single Institution Report. [2023]

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

Nasal Surgery May Improve Upper Airway Collapse in Patients With Obstructive Sleep Apnea: A Drug-Induced Sleep Endoscopy Study. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Death or near-death in patients with obstructive sleep apnoea: a compendium of case reports of critical complications. [2019]