Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT04759157
Eligibility Criteria:
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 exclusion criteria:
1\. Concomitant OSA treatments (bariatric surgery planned in the next 3 months or bariatric surgery in the past year, ear nose and throat surgery for sleep apnea occurring in the 3 months before or planning for within the study period).
Exclusion criteria for both patient and partner include the following:
1. High risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome)
2. History of cognitive or neurological disorders (e.g., dementia, Parkinson's, Multiple Sclerosis)
3. Presence of major psychiatric disorders (e.g., schizophrenia, bipolar disorder), alcohol abuse reported on the Audit-C (score \>4 for men, \>3 for women), drug use (NIDA-Modified ASSIST score \>3)
4. Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe COPD)
5. Use of ASV, VPAP or supplemental oxygen
6. Overnight work \> 1x per month
7. Pregnancy/ desire to become pregnant in the study period
8. Current participation in behavioral sleep treatment (e.g., CBT-I) or completion of CBT-I in the past 3 years
9. Concurrent participation in another clinical trial
10. Caregiving for an infant \< 2 years old or adult who requires overnight assistance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT04759157
Study Brief:
Protocol Section:
NCT04759157