Sleep ApneaPhase 2NCT06649929
Nuestro Sueno: Cultural Adaptation of a Couples Intervention to Improve PAP Adherence and Sleep Health Among Latino Couples With Implications for Alzheimer's Disease Risk
A Phase 2 study testing Couples-based treatment- Patient and Couples-based treatment- Partner in people with Sleep Apnea and Sleep Disturbance, run by University of Utah at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Sleep Apnea, Sleep Disturbance
- What is being tested?
- Couples-based treatment- Patient and Couples-based treatment- Partner
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Mar 2025to 1 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- High risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome)
- History of cognitive or neurological or major psychiatric disorders
- Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe chronic obstructive pulmonary disease
- Patients with need for more complex care (e.g., adaptive servo-ventilation, supplemental oxygen) or concurrent sleep apnea treatment such as bariatric surgery or oral appliance
- Overnight work > 1x per month; 7) Pregnancy/desire to become pregnant in the study period; 8) Current participation in behavioral sleep treatment (e.g., cognitive behavioral therapy for insomnia)
- Concurrent participation in another clinical trial
- Caregiving for an infant < 2 years old or adult who requires overnight assistance
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Utah
Salt Lake City, Utah, 84108
Banner Health
Tuscon, Arizona, 85713
About this study
Official title: Nuestro Sueno: Cultural Adaptation of a Couples Intervention to Improve Positive Airway Pressure Adherence and Sleep Health Among Latino Couples With Implications for Alzheimer's Disease Risk
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:
- Does Nuestro sueno improve the patient's positive airway pressure use over the first 3 months of using it compared to an information control?
- Does Nuestro sueno improve sleep quality for both the patient and partner, compared to an information control?
- Does Nuestro sueno improve other aspects of life including quality of life and memory, compared to an information control?
Read the detailed description
Latino adults in the United States are 1.5 times more likely to develop Alzheimer's disease and related dementias compared to non-Hispanic white adults. Obstructive sleep apnea affects 9.8% of Latino adults and confers a five-fold increased risk of Alzheimer's disease diagnosis. Consequences also extend to the bedpartner, as bedpartners of those with obstructive sleep apnea experience significant sleep disturbances, including sleep fragmentation and 3 times greater risk of insomnia. Given solid mechanistic links between both obstructive sleep apnea and insomnia and Alzheimer's Disease risk, effective obstructive sleep apnea treatment has the potential to promote healthy cognitive aging and reduce Alzheimer's Disease risk for both partners. While the front-line treatment for obstructive sleep apnea, positive airway pressure, is highly effective at reducing obstructive sleep apnea symptoms and may reduce or forestall Alzheimer's Disease risk, its potential is severely diminished, as up to 80% of patients are non-adherent. Extant positive airway pressure adherence interventions are limited in that they are exclusively focused on the individual, neglecting to consider the role of the bedpartner in treatment, and developed primarily in non-Hispanic white populations. Therefore, there is a critical need to develop evidence-based, and culturally-adapted interventions that address the impact of obstructive sleep apnea and its treatment on both partners and within a culturally-tailored framework. The goal of this study is to develop and test "Nuestro Sueño" a culturally-adapted intervention to promote positive airway pressure adherence and sleep health among Latino couples. This study will involve a randomized clinical trial to evaluate the feasibility, treatment satisfaction and preliminary efficacy of Nuestro Sueño versus information control in a sample of 80 patients with obstructive sleep apnea and their partners (i.e., 40 couples per treatment arm) across two sites (Utah and Arizona). The intervention focuses specifically on the interpersonal mechanisms of enhancing dyadic coping and communication, using intervention materials resonant with cultural beliefs and values. If successful, Nuestro Sueño, an innovative and culturally-adapted intervention, has the potential to significantly advance the treatment of obstructive sleep apnea, and may elucidate a critical, modifiable target of prevention and intervention to promote healthy aging and reduce disparities in Alzheimer's Disease risk among Latino couples.
- Conditions
- Sleep Apnea, Sleep Disturbance
- Being tested
- Couples-based treatment- Patient, Couples-based treatment- Partner, Information control- Patient, Information control- Partner
- Keywords
- sleep, couples, positive airway pressure
- Medical subject headings
- Sleep Apnea Syndromes, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples-based treatment- PatientBehavioural
couples will attend 3-telehealth based sessions to provide eduction, increase self-efficacy and teach skils based in principles of brief behavioral therapy for insomnia
Couples-based treatment- PartnerBehavioural
couples will attend 3-telehealth based sessions to provide eduction, increase self-efficacy and teach skils based in principles of brief behavioral therapy for insomnia
Information control- PatientOther
Information only plus treatment as usual
Information control- PartnerOther
Information only plus treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Couples-based treatment- Patient | Experimental | 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 Receives: Behavioral: Couples-based treatment- Patient |
| Couples-based treatment- Partner | Experimental | 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 Receives: Behavioral: Couples-based treatment- Partner |
| Information Control- Patient | Active comparator | In this group, couples will recieve a standardized packet of insomnia about obstructive sleep apnea and starting positive airway pressure. Receives: Other: Information control- Patient |
| Information Control- Partner | Active comparator | In this group, couples will recieve a standardized packet of insomnia about obstructive sleep apnea and starting positive airway pressure. Receives: Other: Information control- Partner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
Defined as the ability to achieve the recruitment goals of the study, to recruit approximately 3-4 couples per month over the study period
Measured: 36 months
Secondary outcomes (2)
Proportion of Days With positive airway pressure Use of 4 Hours or More
The primary efficacy measure for this pilot trial was the proportion of days that patients used CPAP for 4 hours or more over the first 3 months. This 4 hour cutoff was selected becasue it is the minimum usage defined by Medicare and other insurance companies. We obtained patients' CPAP usage by downloading data from their machine using a remote dashboard. Data are only available for patients because partners were not using the treatment. This variable is defined as a proportion, calculated as the number of days with CPAP usage of 4 hours or more divided by the total number of days collected in the 3 month recording period. Scores can range from 0 (no days with use to 1, indicating all days with use of 4 hours or more).
Measured: 3 months
Self-reported Sleep Disturbance
Patient sleep quality on the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance scale, 8 item, version 8b. Models evaluated change from baseline to 3 months. Raw are converted to t-scores, with a range of 28.9-76.5, a mean of 50 and a SD of 10. Higher scores indicate poorer sleep subjective quality.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start20 Mar 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Couples will be randomized 1:1 to intervention and control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Arizona, Banner Health
- Responsible party
- Principal investigator, Kelly Glazer Baron, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649929
- Sponsor's protocol ID
- 00177835
- Other IDs
- 4R33AG084477-02
- Status last verified
- Aug 2026
- First submitted
- 17 Oct 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baron KG, Alcantara C, Lopez I, Euler M, Baucom BRW, Bermudez B, Arones Y, Carbajal-Salisbury S, Fabian G, Grandner M, Gorovoy S, Lopez S, Parthasarathy S, Troxel W. Protocol for Nuestro Sueno: A randomized trial of a couples-based intervention to improve PAP adherence and sleep health among Hispanic patients beginning positive airway pressure (PAP) and their partners. Sleep Med. 2026 Sep;145:109019. doi: 10.1016/j.sleep.2026.109019. Epub 2026 May 15.
PubMed 42176392
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuestro Sueno: Cultural Adaptation of a Couples Intervention to Improve Positive Airway Pressure Adherence and Sleep Health Among Latino Couples With Implications for Alzheimer's Disease Risk
- ClinicalTrials.gov ID
- NCT06649929
- Acronym / sponsor ID
- 00177835
- Conditions
- Sleep Apnea, Sleep Disturbance
- Keywords
- sleep, couples, positive airway pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Arizona, Banner Health
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does Nuestro sueno improve the patient's positive airway pressure use over the first 3 months of using it compared to an information control?
- Does Nuestro sueno improve sleep quality for both the patient and partner, compared to an information control?
- Does Nuestro sueno improve other aspects of life including quality of life and memory, compared to an information control?
Detailed description
Latino adults in the United States are 1.5 times more likely to develop Alzheimer's disease and related dementias compared to non-Hispanic white adults. Obstructive sleep apnea affects 9.8% of Latino adults and confers a five-fold increased risk of Alzheimer's disease diagnosis. Consequences also extend to the bedpartner, as bedpartners of those with obstructive sleep apnea experience significant sleep disturbances, including sleep fragmentation and 3 times greater risk of insomnia. Given solid mechanistic links between both obstructive sleep apnea and insomnia and Alzheimer's Disease risk, effective obstructive sleep apnea treatment has the potential to promote healthy cognitive aging and reduce Alzheimer's Disease risk for both partners. While the front-line treatment for obstructive sleep apnea, positive airway pressure, is highly effective at reducing obstructive sleep apnea symptoms and may reduce or forestall Alzheimer's Disease risk, its potential is severely diminished, as up to 80% of patients are non-adherent. Extant positive airway pressure adherence interventions are limited in that they are exclusively focused on the individual, neglecting to consider the role of the bedpartner in treatment, and developed primarily in non-Hispanic white populations. Therefore, there is a critical need to develop evidence-based, and culturally-adapted interventions that address the impact of obstructive sleep apnea and its treatment on both partners and within a culturally-tailored framework. The goal of this study is to develop and test "Nuestro Sueño" a culturally-adapted intervention to promote positive airway pressure adherence and sleep health among Latino couples. This study will involve a randomized clinical trial to evaluate the feasibility, treatment satisfaction and preliminary efficacy of Nuestro Sueño versus information control in a sample of 80 patients with obstructive sleep apnea and their partners (i.e., 40 couples per treatment arm) across two sites (Utah and Arizona). The intervention focuses specifically on the interpersonal mechanisms of enhancing dyadic coping and communication, using intervention materials resonant with cultural beliefs and values. If successful, Nuestro Sueño, an innovative and culturally-adapted intervention, has the potential to significantly advance the treatment of obstructive sleep apnea, and may elucidate a critical, modifiable target of prevention and intervention to promote healthy aging and reduce disparities in Alzheimer's Disease risk among Latino couples.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Couples will be randomized 1:1 to intervention and control
| Arm | Type | Receives |
|---|---|---|
| Couples-based treatment- Patient | Experimental | Behavioral: Couples-based treatment- PatientIn 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 |
| Couples-based treatment- Partner | Experimental | Behavioral: Couples-based treatment- PartnerIn 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 |
| Information Control- Patient | Active comparator | Other: Information control- PatientIn this group, couples will recieve a standardized packet of insomnia about obstructive sleep apnea and starting positive airway pressure. |
| Information Control- Partner | Active comparator | Other: Information control- PartnerIn this group, couples will recieve a standardized packet of insomnia about obstructive sleep apnea and starting positive airway pressure. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- High risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome)
- History of cognitive or neurological or major psychiatric disorders
- Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe chronic obstructive pulmonary disease
- Patients with need for more complex care (e.g., adaptive servo-ventilation, supplemental oxygen) or concurrent sleep apnea treatment such as bariatric surgery or oral appliance
- Overnight work > 1x per month; 7) Pregnancy/desire to become pregnant in the study period; 8) Current participation in behavioral sleep treatment (e.g., cognitive behavioral therapy for insomnia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couples-based treatment- Patientcouples will attend 3-telehealth based sessions to provide eduction, increase self-efficacy and teach skils based in principles of brief behavioral therapy for insomnia | Behavioural | Couples-based treatment- Patient |
| Couples-based treatment- Partnercouples will attend 3-telehealth based sessions to provide eduction, increase self-efficacy and teach skils based in principles of brief behavioral therapy for insomnia | Behavioural | Couples-based treatment- Partner |
| Information control- PatientInformation only plus treatment as usual | Other | Information Control- Patient |
| Information control- PartnerInformation only plus treatment as usual | Other | Information Control- Partner |
Primary outcome
Recruitment Feasibility
Time frame: 36 months
Defined as the ability to achieve the recruitment goals of the study, to recruit approximately 3-4 couples per month over the study period
2 secondary outcomes
Proportion of Days With positive airway pressure Use of 4 Hours or More
Time frame: 3 months
Self-reported Sleep Disturbance
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 42176392Baron KG, Alcantara C, Lopez I, Euler M, Baucom BRW, Bermudez B, Arones Y, Carbajal-Salisbury S, Fabian G, Grandner M, Gorovoy S, Lopez S, Parthasarathy S, Troxel W. Protocol for Nuestro Sueno: A randomized trial of a couples-based intervention to improve PAP adherence and sleep health among Hispanic patients beginning positive airway pressure (PAP) and their partners. Sleep Med. 2026 Sep;145:109019. doi: 10.1016/j.sleep.2026.109019. Epub 2026 May 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Couples-based treatment- Patient and Couples-based treatment- Partner in people with Sleep Apnea and Sleep Disturbance, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06649929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.