CLINICAL TRIAL

Venlafaxine for Sleep Apnea Syndromes

Recruiting · 18+ · All Sexes · La Jolla, CA

This study is evaluating whether a combination of drugs may help treat obstructive sleep apnea.

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About the trial for Sleep Apnea Syndromes

Eligible Conditions
Sleep Apnea, Obstructive · Sleep Apnea Syndromes · Obstructive Sleep Apnea (OSA)

Treatment Groups

This trial involves 2 different treatments. Venlafaxine is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Placebo
DRUG
+
Venlafaxine
DRUG
+
Acetazolamide
DRUG
+
Eszopiclone
DRUG
Experimental Group 2
Placebo
DRUG
+
Venlafaxine
DRUG
+
Acetazolamide
DRUG
+
Eszopiclone
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Venlafaxine
FDA approved
Acetazolamide
FDA approved
Eszopiclone
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
BMI 18-40 kg/m2
Untreated Moderate or Severe OSA (AHI during supine NREM sleep >15/h) with a fraction of hypopneas >25% of all events
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 nights
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 nights
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 nights.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Venlafaxine will improve 1 primary outcome and 7 secondary outcomes in patients with Sleep Apnea Syndromes. Measurement will happen over the course of 3 nights.

Percent Responders
3 NIGHTS
Responders will be defined as a drop in AHI>50% to <10/h.
3 NIGHTS
Apnea Hypopnea Index (AHI) during supine Non-Rapid Eye Movement (NREM) sleep
3 NIGHTS
The AHI is a measure of sleep apnea severity and is defined as the number of apneas (no breathing for 10+ seconds) and hypopneas (reduced breathing for 10+ seconds associated with a >=3% desaturation or cortical arousal) per hour of sleep. To avoid confounding by sleep stages and positions across study nights we will focus on the AHI during supine NREM sleep.
3 NIGHTS
Vigilance
3 NIGHTS
Vigilance will be assessed using the 5-minute psychomotor vigilance test (PVT) in the morning following the overnight sleep study.
3 NIGHTS
SpO2 Nadir
3 NIGHTS
The lowest measured blood oxygen saturation during the overnight sleep study measured in percent.
3 NIGHTS
Sleep Quality: PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance
3 NIGHTS
Sleep quality will be assessed based on a modified 8-question PROMIS Sleep Disturbance questionnaire in the morning following the overnight sleep study. The raw score ranges from 8 to 40 and is translated into a T-score, a standardized score with a mean of 50 and a standard deviation of 10. Greater T-scores indicate greater sleep disturbance.
3 NIGHTS
Pathophysiological Traits
3 NIGHTS
Changes in pathophysiological traits (Vpassive, Vactive, Arousal Threshold, Loop Gain) will be quantified as %Veupnea from polysomnography data using a validated algorithm.
3 NIGHTS
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Who is running the study

Principal Investigator
C. S.
Christopher Schmickl, MD
University of California, San Diego

Patient Q & A Section

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

Can sleep apnea syndromes be cured?

Symptom improvement occurs with CPAP therapy, but the magnitude is low. The authors conclude that improvements are not sufficient to warrant CPAP therapy discontinuation, and further research is needed to better understand the mechanisms contributing to treatment failure.

Anonymous Patient Answer

What are the signs of sleep apnea syndromes?

These are the most well-recognized symptoms of [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) syndrome: daytime symptoms of apnea, nasal congestion and daytime sleepiness. Many people are unaware of their sleep apnea-related symptoms and would not seek treatment if they thought they had only sleep apnea without apnea. The symptoms of sleep apnea that can be treated with CPAP often improve and improve treatment adherence after 3 months of treatment. The best ways to increase CPAP use among patients with sleep apnea are being educated about the disease, using the CPAP device, not missing doses, and having a spouse involved in set-up and use of the CPAP device. Sleep apnea may also have other causes besides sleep.

Anonymous Patient Answer

What are common treatments for sleep apnea syndromes?

Patients presenting to the sleep center need more than one treatment option. Patients with CSAHS should be treated with continuous positive airway pressure (CPAP) in addition to other therapies. CPAP can reduce some of the most troubling symptoms of sleep apnea including daytime sleepiness and fatigue. Patients with OSAHS or sleep-disordered breathing do not need CPAP. Patients with OSASH and obstructive sleep apnia should be treated with CPAP or oral appliance or trimmer to treat central sleep apnea and a continuous nasal obstruction that causes daytime snoring.

Anonymous Patient Answer

What is sleep apnea syndromes?

At least 1.2% of U.S adults have sleep apnoea with or without hypopnoea during sleep. If sleep apnoea is more common than previously estimated, this adds more to the burden on the healthcare system, as sleep apnoea is an unrecognized cause of excessive sleepiness. Clinicians should pay close attention to patients with anemia.

Anonymous Patient Answer

What causes sleep apnea syndromes?

The majority of subjects with sleep disordered breathing had OSA. Moreover, about a third of our subjects with OSA met the AASLD-2003 criteria for the diagnosis of sleep apnea. The prevalence of OSA in the whole population was similar because of the low sensitivity of the polysomnographies. Data from a recent study may help us to understand the underlying etiopathogenesis of OSA in a population of patients treated in a Sleep Center.

Anonymous Patient Answer

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

Approximately 14 million Americans are sleep apneic at some time in their lives. Those who are at risk (including those who will develop an apnea during their lifetime) are estimated to have a 30% to 40% chance of having clinically significant sleep apnea after the development of sleep apnea during their lifetime. To be counted as sleep apnea, an individual must have a minimum severity of apnea (defined as apnea with or without other symptoms) and must have been diagnosed with sleep apnea on the basis of the patient's history, examination, or in a subset of patients, other available corroborating tests.

Anonymous Patient Answer

Has venlafaxine proven to be more effective than a placebo?

There is no evidence that patients who take venlafaxine are less affected by [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) compared to patients who receive a placebo. Venlafaxine is not more effective in alleviating sleep disturbance in OSA patients compared to placebo. Future studies should focus on sleep architecture parameters rather than on the apnea-hypopnea hypopnoea index.

Anonymous Patient Answer

What are the latest developments in venlafaxine for therapeutic use?

Venlafaxine exerts its actions via modulation of the expression of various proteins and transcription factors involved in several physiological processes involved in sleep regulation and modulation. Thus, venlafaxine has been shown to have an antidepressant-like action, with an optimized action profile on sleep and circadian rhythms, and is beneficial in the treatment of insomnia, circadian rhythm sleep disorders (CRSD), and insomnia accompanying bipolar disorder.

Anonymous Patient Answer

Does sleep apnea syndromes run in families?

The finding of familial occurrences of OSAS, and OSAS without a known behavioral or other family history, may suggest a new and specific genetic etiology for OSAS in certain cases. The occurrence of OSAS with OSAS+PAP is associated with the occurrence of the OSAS-PAP+ family member, providing support for genetic heterogeneity of the OSAS syndromes in these patients.

Anonymous Patient Answer

What is the average age someone gets sleep apnea syndromes?

Approximately half of all men and a third of all women with sleep apnea have been undiagnosed. Older people are over-represented among sufferers of sleep apnea. People under 60 years may be the most likely to be misdiagnosed or undiagnosed. Sleep apnea may be a symptom and potentially a cause of many other medical ailments because the majority of sufferers continue to have symptoms after being diagnosed. Further studies are required before the full extent of untreated sleep apnea can be clarified.

Anonymous Patient Answer

Is venlafaxine typically used in combination with any other treatments?

Venlafaxine is typically indicated for treatment of depression in people with some co-existing physical disorders. These psychiatric disorders may contribute to OSA, and vice versa, and, if OSA is untreated with adequate therapy, it may worsen symptoms of depression.

Anonymous Patient Answer

Have there been any new discoveries for treating sleep apnea syndromes?

In the last 15 years or so treatment options for sleep apnea syndromes have changed dramatically. There are now a large number of treatments and devices used on a routine basis. Most patients with sleep apnea will have good results from a number of these treatments without using CPAP for long-term control. There is also evidence that some CPAP use may help to reduce the number of episodes of apnea, although it does not provide long term control. Patients with sleep apnea and cardiovascular complications or other issues should seek the guidance of a physician. If treatment for sleep apnea alone is no longer sufficient to control a patient's apnea, it is unlikely that CPAP therapy will assist.

Anonymous Patient Answer
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