SAM Clinic Intervention for Apnea

Phase-Based Estimates
1
Effectiveness
1
Safety
Cleveland Clinic Foundation, Cleveland, OH
Apnea+2 More
SAM Clinic Intervention - Other
Eligibility
18+
All Sexes
Eligible conditions
Apnea

Study Summary

This study is evaluating whether a group intervention may help improve adherence to positive airway pressure machines for individuals with obstructive sleep apnea.

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Eligible Conditions

  • Apnea
  • Sleep Apnea Syndromes
  • Sleep Apnea

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether SAM Clinic Intervention will improve 2 primary outcomes, 5 secondary outcomes, and 1 other outcome in patients with Apnea. Measurement will happen over the course of Baseline to 3 month follow up.

Month 3
Changes in PAP Barrier questionnaire (eg. mask fit, nasal congestion, pressure intolerance) from baseline to 1 month and 3 month follow up.
Hours of PAP usage (>4 hours) in last 4 weeks and at 12 weeks.
Measure changes in daytime sleepiness at 4 weeks and then at 12 weeks in PAP adherence group and in usual care group in study sample.
Measure changes in depressive symptoms at 4 weeks and then at 12 weeks in PAP adherence group and in usual care group in study sample.
Measure changes in fatigue measures at 4 weeks and then at 12 weeks in PAP adherence group and in usual care group in study sample.
Measure changes in global health measures at 4 weeks and then at 12 weeks in PAP adherence group and in usual care group in study sample.
Measure changes in sleep related impairment measures at 4 weeks and then at 12 weeks in PAP adherence group and in usual care group in study sample.
Percent days of PAP use in last 4 weeks and at 12 weeks.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
SAM Clinic Intervention

This trial requires 166 total participants across 2 different treatment groups

This trial involves 2 different treatments. SAM Clinic Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

SAM Clinic Intervention
Other
Participants will attend a sleep apnea management group based intervention to improve PAP adherence.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 3 month follow up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 3 month follow up for reporting.

Who is running the study

Principal Investigator
R. M.
Reena Mehra, MD
The Cleveland Clinic

Closest Location

Cleveland Clinic Foundation - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Non-sleep specialists who treat patients with OSA mainly include primary care providers. show original
≥18 years old
is associated with increased risk for automobile crashes If you have moderate to severe OSA (apnea hypopnea index (AHI)≥15 events/hr) on polysomnogram (PSG), you are at an increased risk for automobile crashes. show original
ago! A new Pap smear testing service has been set up within the past month. show original
Sub-optimal PAP adherence by objective PAP adherence data (<70 % usage and <4 hours of average PAP usage)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get apnea a year in the United States?

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About 1.7 million Americans have a complaint of snoring or apnea each year. apnoea occurs approximately 30 million times a year in the U.S., making it an important aspect of health.

Unverified Answer

What causes apnea?

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Apnea is caused by abnormalities in the central pattern generator that results in a failure in voluntary respiratory drive. Hypoxia is an important stimulus that stimulates respiratory apnea. Dysfunction of central patterns, respiratory drive and central control of respiration, particularly in the control of ventilation in response to hypoxia, are implicated in apnea of prematurity, and may contribute to its pathogenesis.

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What are the signs of apnea?

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Changes in breathing during sleep, and sleep apnea, may be noticeable from the signs of excessive daytime sleepiness, irritability, lethargy, and poor concentration that many patients with sleep apnea experience. As more sufferers of sleep apnea go unrecognized, the health care profession will experience the most damage to the patient and to society when this unrecognized health problem begins. More studies of sleep apnea in a wide variety of sleep centers and in the community-wide population are needed.

Unverified Answer

What is apnea?

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Even after adjusting for age, gender, and marital status, the risk for [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) is increased in children of African Americans. The risk for obstructive sleep apnea is related to the severity of obesity. In a recent study, findings may be explained by a stronger association of obesity with the onset of sleep abnormalities in African Americans.

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Can apnea be cured?

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There is a significant benefit in not using positive airway pressure, but a risk of worsening hypoxia or pulmonary hypertension. There is a similar benefit in eliminating sleep apnea without using positive airway pressure. Some patients do well with nasal Continuous Positive Airway Pressure alone.

Unverified Answer

What are common treatments for apnea?

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Most studies reviewed in this paper focus on specific agents and therapies that are commonly prescribed by adult patients for the treatment of apnea. Examples include (1) medications to treat or prevent asthma, (2) medications that have been approved by the FDA for use in treating obstructive [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea), (3) medications used to stabilize heart rhythm disturbances during sleep. None of the studies reviewed describes a common medications used by patients to treat and/or prevent apnea in infants. It is imperative for caregivers to be aware of the most commonly used medications to treat apnea in infants.

Unverified Answer

What is the latest research for apnea?

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It is difficult to know all the research for a condition, because the research is in the form of [randomized controlled trials], which take a long time to complete. In order to keep up to date, please take a look at the [APNA-CATEGORIES] (APNA = Apnea – Category) by [www.apnacategories.com]. You can find reviews for every category for recent events and clinical trials.

Unverified Answer

How serious can apnea be?

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[Approximately 3% of normal adults experience apnea annually, with rates of asymptomatic cases rising to 40% in patients > 60 years old (3)(4). While the diagnosis and treatment of apnea are often challenging and are best managed by a professional with the appropriate knowledge and training, the complications it can cause, particularly if untreated, are quite serious. In addition to having to decide whether to treat apnea, patients will have to deal with the consequences of untreated apnea, including problems with concentration and sleepiness. In the event of complications, apnea can contribute to morbidity and mortality, requiring urgent intervention to ensure that breathing and circulation are maintained safely.

Unverified Answer

What is the average age someone gets apnea?

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If you are a health care provider and you're being asked to make a diagnosis in the ED, you should expect to be asked about apnea, and therefore have a basic understanding of what is normal and abnormal, as well as the average age that is diagnosed.\n

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Has sam clinic intervention proven to be more effective than a placebo?

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It was concluded that the use of a sam clinic for [smoking cessation](https://www.withpower.com/clinical-trials/smoking-cessation) was more effective than a placebo for the cessation of smoking behavior. The sam clinic was particularly effective in smokers who were older and who had low motivation.

Unverified Answer

Who should consider clinical trials for apnea?

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Recent findings of these 2 retrospective analyses support that patients who present with persistent abnormal respiratory events after surgery or with postoperative apnea may find them helpful when considering clinical trials.

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What are the common side effects of sam clinic intervention?

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It is found that Sams could be an effective treatment option for obstructive sleep apnea. However, they should be observed the common side effects such as snoring sound, headaches, dizziness, etc.

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