Obstructive Sleep Apnea
Conditions
Keywords
OSA
Brief summary
The purpose of this study is to develop, refine and evaluate the feasibility of a novel couples-based intervention to improve adherence for patients with obstructive sleep apnea (OSA).
Detailed description
This study will develop and test a novel couples-based intervention for the treatment of OSA and sleep health among older couples. The focus of this study is patient who are starting CPAP treatment and their partners. Couples will be randomized to a 3-session sleep health intervention delivered via telehealth or to standard educational support for CPAP. The intervention is based on a transdiagnostic model of sleep and circadian disorders (TransS-C) and rooted in the idea that older adults with OSA are often also having other sleep problems, and that OSA is best treated in the couples context.
Interventions
BEHAVIORALCouples-based treatment
Couples will attend 3, video based sessions for couples-based treatment
Patients will receive standardized educational materials
Sponsors
National Institute on Aging (NIA)
RAND
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigators and outcomes assessors will not have knowledge of the randomization table. Participants will be reminded to not to tell the outcomes assessors their group. Only the statistician and interventionist will be aware of the group.
Intervention model description
This is a dyadic study. Couples are randomly assigned as a dyad.
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patient and partner inclusion criteria: 1. Age \>=50 2. Access to cellular (active data plan) or Wi-Fi, in order to complete the telehealth intervention. Patients inclusion criteria: 1. Diagnosed with OSA (AHI\>10 or AHI\>5 with impairment) and intend to start PAP treatment 2. PAP naïve or non-use of PAP for at least 3 years 3. Married or cohabiting with a romantic partner for \>1 year 4. Able to read/write English. Partner inclusion criteria: 1. Able to read/write English 2. PROMIS sleep disturbance score \>55 in either patient or partner, or desire to improve sleep.
Exclusion criteria
Patient only
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility | study duration | Defined as the ability to achieve the recruitment goals of the study, to recruit approximately 3-4 couples per month over the study period (12 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Days With PAP Use of 4 Hours or More | 3 months | The primary efficacy measure for this pilot trial was the percentage 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). |
| Self-reported Sleep Disturbance | 3 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intervention Completion | intervention period, 1 month | Percentage of participants who completed the intervention sessions: 3 sessions for the couples-based treatment group and 1 handout and phone call for the information control group |
| Retention | 3 months | We defined retention as the number of participants completing the 3 month follow-up. Our goal was to acheive at least 85% retention. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from June 2021 to October 2023 from the University of Utah Sleep Wake Center among patients who were undergoing sleep apnea testing (polysomnography and home sleep testing) for suspected sleep apnea. 84 participants were consented and 74 continued to baseline assessment. A total of 10 individuals (5 couples) did not complete baseline for the following reason: 4 couples became ineligible (did not start PAP, started oxygen), 1 couple did not complete baseline.
Pre-assignment details
Participants were recruited if they were planning to begin PAP treatment for obstructive sleep apnea.
Participants by arm
| Arm | Count |
|---|---|
| Couples-based Treatment- Patient Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.
Couples-based treatment: Couples will attend 3, video based sessions for couples-based treatment | 20 |
| Couples-based Treatment- Partner Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.
Couples-based treatment: Couples will attend 3, video based sessions for couples-based treatment | 20 |
| Standard Information Control- Patient Participants will receive treatment as usual and also standardized information about OSA and CPAP.
Standardized education: Patients will receive standardized educational materials | 17 |
| Standard Information Control- Partner Participants will receive treatment as usual and also standardized information about OSA and CPAP.
Standardized education: Patients will receive standardized educational materials | 17 |
| Total | 74 |
Baseline characteristics
| Characteristic | Couples-based Treatment- Patient | Couples-based Treatment- Partner | Standard Information Control- Patient | Standard Information Control- Partner | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 13 Participants | 8 Participants | 7 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 7 Participants | 9 Participants | 10 Participants | 39 Participants |
| Age, Continuous | 62.2 years STANDARD_DEVIATION 7.4 | 59.9 years STANDARD_DEVIATION 7.7 | 66.1 years STANDARD_DEVIATION 8.8 | 64.3 years STANDARD_DEVIATION 11.6 | 63.2 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 16 Participants | 16 Participants | 15 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 18 Participants | 18 Participants | 16 Participants | 13 Participants | 65 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 17 participants | 17 participants | 74 participants |
| Sex: Female, Male Female | 9 Participants | 11 Participants | 8 Participants | 9 Participants | 37 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 9 Participants | 8 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 17 | 0 / 17 |
Outcome results
Primary
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 (12 months)
Time frame: study duration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Recruitment Feasibility | 42 Participants |
| Partners | Recruitment Feasibility | 42 Participants |
Secondary
Percentage of Days With PAP Use of 4 Hours or More
The primary efficacy measure for this pilot trial was the percentage 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).
Time frame: 3 months
Population: Patients who had their PAP machine removed were given a zero at 3 months (n=2 patients)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients | Percentage of Days With PAP Use of 4 Hours or More | .73 proportion of nights with CPAP >=4h | Standard Deviation 0.08 |
| Partners | Percentage of Days With PAP Use of 4 Hours or More | .72 proportion of nights with CPAP >=4h | Standard Deviation 0.07 |
p-value: 0.3mixed model
Secondary
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.
Time frame: 3 months
Population: Baseline PROMIS sleep quality data are missing for this variable for one couple in the intervention group and one couple in the control group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients | Self-reported Sleep Disturbance | Baseline | 55.3 t-score | Standard Deviation 6.8 |
| Patients | Self-reported Sleep Disturbance | 3 months | 49.6 t-score | Standard Deviation 5.9 |
| Partners | Self-reported Sleep Disturbance | 3 months | 48.3 t-score | Standard Deviation 6.3 |
| Partners | Self-reported Sleep Disturbance | Baseline | 50.6 t-score | Standard Deviation 5.7 |
| Standard Information Control- Patient | Self-reported Sleep Disturbance | Baseline | 56.7 t-score | Standard Deviation 7.8 |
| Standard Information Control- Patient | Self-reported Sleep Disturbance | 3 months | 51 t-score | Standard Deviation 6.1 |
| Standard Information Control- Partner | Self-reported Sleep Disturbance | Baseline | 48.6 t-score | Standard Deviation 6.4 |
| Standard Information Control- Partner | Self-reported Sleep Disturbance | 3 months | 48.7 t-score | Standard Deviation 6.9 |
Comparison: We conducted multilevel models evaluating sleep disturbance score by assessment, group and patient versus partner status.p-value: 0.20695% CI: [-6.63, 1.43]Mixed Models Analysis
Other Pre-specified
Intervention Completion
Percentage of participants who completed the intervention sessions: 3 sessions for the couples-based treatment group and 1 handout and phone call for the information control group
Time frame: intervention period, 1 month
Population: 100% of participants completed the planned intervention for their assigned group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Intervention Completion | 20 Participants |
| Partners | Intervention Completion | 20 Participants |
| Standard Information Control- Patient | Intervention Completion | 17 Participants |
| Standard Information Control- Partner | Intervention Completion | 17 Participants |
Other Pre-specified
Retention
We defined retention as the number of participants completing the 3 month follow-up. Our goal was to acheive at least 85% retention.
Time frame: 3 months
Population: We acheived 100% retention, with all participants completing the 3 month follow-up assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Retention | 20 Participants |
| Partners | Retention | 20 Participants |
| Standard Information Control- Patient | Retention | 17 Participants |
| Standard Information Control- Partner | Retention | 17 Participants |