Please assess the completion status of the following clinical trial:

Trial Title: Sleep Apnea Intervention for Cardiovascular Disease Reduction

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: None
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Obstructive apnea hypopnea index (AHI) ≥ 15~* Age 45-75 years, or 55 to 75 yrs if without established Cardiovascular Disease (CVD)~* Ability to provide informed consent, with the patient and physician acknowledging accepting uncertainty on the role of PAP in CVD prevention.~* Established CVD,or having diabetes mellitus, defined by one or more of the following:~  1. Prior myocardial infarction~ 2. Coronary artery revascularization procedure (≥4 months before study entry)~ 3. Angiographically documented stenosis (\>70%) of a major coronary artery~ 4. Prior ischemic stroke without major functional impairment~ 5. Diabetes mellitus treated with medication or ≥ 2 fasting glucose levels ≥ 126 mg/dl~OR~Three or more of the following established CVD risk factors:~1. Hypertension treated with medications or systolic BP \> 140 or diastolic BP \> 90 on ≥ 2 occasions~2. Male sex~3. BMI ≥ 30~4. Total cholesterol \> 240 mg/dl or LDL cholesterol \> 160 mg/dl or HDL \< 45 mg/dl~5. \> 10 pack years of smoking~Exclusion Criteria:~* Diagnosed heart failure with known cardiac ejection fraction of \< 35% or New York Heart Association (NYHA) class 3 or 4 status~* Less than 4 months since myocardial infarction (MI), stroke or revascularization procedure~* Poorly controlled hypertension (\>170/\>100)~* Prior stroke with functional impairment interfering with ability to complete the protocol~* Severe uncontrolled medical problems or medications that may influence measurements or impair ability to participate in the study exams (e.g. oral steroids; chronic opioid use; self- reported chronic kidney disease or, if measured, creatinine \> 2.5 mg/dl or glomerular filtration rate (GFR) \< 30; anemia with Hgb \< 10, etc.)~* Resting oxygen saturation \< 90% or nocturnal oxygen saturation \<85% for \> 10% of the sleep period;~* Use of prescribed PAP for sleep apnea within the prior 2 years~* Report of inability to spend \>6 hrs in bed~* Any use of prescribed PAP for sleep apnea~* Severe sleepiness defined by an Epworth Sleepiness Score of \>14 or report of falling asleep driving in the prior 2 years~* Working as a professional driver~* Low risk related to having sleep apnea defined by a Berlin Score \< 2~* Central sleep apnea, with \>50% of respiratory events classified as central apneas~* Refusal to consider PAP use after an initial split-night PAP study (pre-randomization)~* Concurrent involvement in another research study that will result in a conflict as determined by study doctors

- Gender: ALL
- Minimum Age: 45 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Conservative Medical Therapy (CMT) (Type: PLACEBO_COMPARATOR): All participants will meet with a research assistant who will provide \~30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breath Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
- Sham PAP (Sham) (Type: SHAM_COMPARATOR): In addition to receiving CMT, participants in this treatment arm will receive a sham-CPAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active PAP arms.~The treatment visit schedule is outlined below.~1. PAP Initial Set-Up~2. 1-week follow up~3. 1-month follow up~4. 3-month follow up~5. 6-month follow up~6. 9-month follow up (will not occur if on a 6-month follow-up protocol)~It is estimated that each in-person follow-up adherence visit with the PAP specialist would last \~30 minutes.
- Active PAP with RT Support (Active-Beh) (Type: ACTIVE_COMPARATOR): In addition to receiving CMT, participants will receive active-PAP. The treatment visit schedule is outlined below.~1. PAP Initial Set-Up~2. 1-week follow up (FU)~3. 1-month FU~4. 3-month FU~5. 6-month FU~6. 9-month FU (12-month follow-up protocol only)~All visits will take place with a PAP specialist. All follow-up visits will be anchored to the initial PAP set-up visit. At these visits, using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. Each follow-up visit with the PAP specialist will last 30 minutes.
- Active PAP with Behavioral Modification (Active+Beh) (Type: ACTIVE_COMPARATOR): In addition to receiving CMT and active-PAP, participants will have behavioral intervention sessions to promote PAP adherence. The treatment visit schedule is outlined below:~Visits with Behavioral Interventionist (in addition to active-PAP treatment visits):~1. PAP Initial Set-Up (in-person, 1-hr)~2. 1-week follow-up (FU) (in-person, 1-hr)~3. 1-month FU~4. 2-month FU~5. 3-month FU~6. 5-month FU~7. 8-month FU (12-month follow-up protocol only)~All follow-up visits will be anchored to the initial PAP set-up visit. PAP treatment visits will occur as outlined in the active-PAP arm.~All behavioral intervention visits will be 30-min phone calls, unless otherwise noted. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete