Comparison of Zzoma Positional Sleep Therapy in Patients with OSA

Obstructive Sleep Apnea (OSA) Syndrome is highly prevalent, affecting 2% of women and 4% of men in the general population. Recent studies have identified OSA as an independent risk factor for a number of cardiovascular diseases, including hypertension, stroke, congestive heart failure and coronary artery disease. CPAP is the most common treatment for patients with OSA, as it has been shown to be efficacious. However, compliance with CPAP therapy is poor, with studies demonstrating compliance rates of less than 50%. The treatment is often uncomfortable and burdensome to the patient, with reported intolerance to the pressure, nasal congestion, claustrophobia or discomfort related to the mask. Other therapeutic options include surgical intervention of the upper airway, weight loss, the use of an oral appliance, and when indicated, positional therapy.

Recent data has identified that positional obstructive sleep apnea, where patients have the majority of their sleep-disordered breathing events when lying supine, is quite prevalent in patients with mild and moderate OSA. Using the definitions of the American Academy of Sleep Medicine (AASM), Mador et al found that 50% of patients with mild OSA (apnea-hypopnea index [AHI] of 5-15 events/hr) and 19% of patients with moderate OSA (AHI of 15-30 events/hr) have positional OSA. Again, using the AASM definition of normal as being < 5 events/hr, these patients when in the non-supine position would decrease their AHI to < 5 events/hr.

As a result, we evaluated the effects of a new positional device (Zzoma Positional Device) in patients with positional OSA and compared it to conventional CPAP therapy, specifically utilizing definitions of success as a normalization of the AHI to < 5 events/hr. The Zzoma Positional Device has been designed along the “ball in the backpack” concept that has been used in previous studies. However, the shape and the design of the Zzoma Positional Device has been improved over this simplistic concept in order to maximize effectiveness and comfort in keeping the patient sleeping in the lateral position.

There were 4 major findings in this study:

1. In patients with positional OSA, Zzoma is equivalent to CPAP therapy at normalizing the AHI to less than 5 events/hr in addition to decreasing the AHI by over 50.

2. Zzoma is similar to CPAP therapy in regards to effects on sleep quality and nocturnal oxygenation.

3. There is minimal night-to-night variability in the non-supine AHI in patients with positional OSA.

4. Zzoma is effective at maintaining patients in the non-supine position throughout the night.

Click Here to download the full clinical study.

American College of CHEST: Physicians Prevalence of Positional Sleep Apnea in Patients Undergoing Polysomnography. Study Objectives: The primary aim of this study was to determine the prevalence of positional obstructive sleep apnea using a functional definition. Positional sleep apnea was defined as a total apnea-hypopnea index (AHI) >4 with a > 50% reduction in the AHI between the supine and nonsupine postures, and an AHI that normalizes (AHI < 5) in the nonsupine posture. A secondary aim was to determine if positional sleep apnea can be diagnosed accurately during a split-night study.  Read More…

National Heart Lung and Blood Institute: What Is Sleep Apnea? Sleep apnea often goes undiagnosed. Doctors usually can’t detect the condition during routine office visits. Also, there are no blood tests for the condition. View an animation that shows how air flow to the lungs can be blocked, causing sleep apnea. Learn about the side effects of untreated sleep apnea.  Read More…

JCSM: Clinical Guideline for the Evaluation, Management and Long-term Care of Obstructive Sleep Apnea in Adults. Guideline Objective: This guideline is designed to assist primary care providers as well ass sleep medicine specialists, surgeons, and dentists who care for patients with OSA by providing a comprehensive strategy for the evaluation, management and long-term care of adult patients with OSA.  Read More…

The 2009 AASM guidelines relating to treatment of positional therapy state:

“Positional therapy, consisting of a method that keeps the patient in a non-supine po­sition, is an effective secondary therapy or can be a supplement to primary therapies for OSA in patients who have a low AHI in the non-supine versus that in the supine position (Guideline).21 Because not all patients normalize AHI when non-supine, cor­rection of OSA by position should be documented with PSG before initiating this form of treatment as a primary therapy (Consensus). A positioning device (e.g., alarm, pillow, back­pack, tennis ball) should be used when initiating positional therapy (Consensus). To establish the efficacy of a positioning device in the home, providers should consider use of an objec­tive position monitor (Consensus). Treatment specific outcome indicators to monitor with therapy include: self-reported com­pliance, objective position monitoring, side effects, and symp­tom resolution (Consensus).”

If we can be of any assistance to you or your patients, please do not hesitate to contact us directly at
1.877.799.9662.

Navigating the Insurance Reimbursement Process

Zzoma is an out-of-pocket expense that you may be refunded for by your private healthcare insurer. Refund approval and percentage depends on your policy.

If you'd like to receive pre-approval we suggest for you to start by calling the 800 # on the back of your insurance card. Ask them their policy on the equipment code E1399 as a medical necessity. Explain to the customer care representative that you have been diagnosed with obstructive sleep apnea and have been prescribed Zzoma as a medical device. Let them know that you do have a medical necessity letter (click for a sample).

Most insurance companies will have you purchase items and then download a claim form from their website. We suggest submitting a copy of your prescription, medical necessity letter and receipt with your form. We are not given permission to access your health coverage so please be sure to write your own address on the forms for correspondence.

The following information is a collection of the details you may need for your refund.

Manufacturer/Servicing Provider Name: Sleep Specialists, LLC (DBA 2Z Medical)
TAX ID: 20-5914787
Physical Address: 45 E City Ave PMB 325 Bala Cynwyd PA 19004
Telephone: 1.877.799.9662
Fax: 1.267.222.1000
Active HCPCS Code/Equipment Code & Description: E1399 Durable Medical Equipment Misc Code
Production Name: Zzoma Positional Device
Regulatory Class: II (prescription only)
FDA Clearance 510(k): K100160
ICD-9 Diagnosis Code: 327.23 or Obstructive Sleep Apnea

If your insurance company does not cover for Zzoma, it may be covered under your pre-tax cafeteria plan (IRS Section 125).

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Navigating the Insurance Reimbursement Process

Zzoma is an out-of-pocket expense that you may be refunded for by your private healthcare insurer. Refund approval and percentage depends on your policy.

If you'd like to receive pre-approval we suggest for you to start by calling the 800 # on the back of your insurance card. Ask them their policy on the equipment code E1399 as a medical necessity. Explain to the customer care representative that you have been diagnosed with obstructive sleep apnea and have been prescribed Zzoma as a medical device. Let them know that you do have a medical necessity letter (click for a sample).

Most insurance companies will have you purchase items and then download a claim form from their website. We suggest submitting a copy of your prescription, medical necessity letter and receipt with your form. We are not given permission to access your health coverage so please be sure to write your own address on the forms for correspondence.

The following information is a collection of the details you may need for your refund.

Manufacturer/Servicing Provider Name: Sleep Specialists, LLC (DBA 2Z Medical)
TAX ID: 20-5914787
Physical Address: 45 E City Ave PMB 325 Bala Cynwyd PA 19004
Telephone: 1.877.799.9662
Fax: 1.267.222.1000
Active HCPCS Code/Equipment Code & Description: E1399 Durable Medical Equipment Misc Code
Production Name: Zzoma Positional Device
Regulatory Class: II (prescription only)
FDA Clearance 510(k): K100160
ICD-9 Diagnosis Code: 327.23 or Obstructive Sleep Apnea

If your insurance company does not cover for Zzoma, it may be covered under your pre-tax cafeteria plan (IRS Section 125).

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Zzoma Application Instructions:

  • Place the device on your back and bring the straps around so they are in front of you.
  • Position the device so the Velcro straps are at the level of your chest.
  • Adjust the Velcro straps for fit and comfort and secure together.
  • Lie on either side in a comfortable position and go to sleep.

Warning:
The user of this pillow should consult with their physician if the following symptoms continue:

  • Frequent excessive daytime sleepiness
  • Periods of not breathing, as observed by bed partners
  • Awakening short of breath, choking or gagging
  • Heavy snoring
Contraindictions:
  • A history of heart diseases
  • Being substantially overweight
  • Not for use by infants or children
  • Do not use if pain or discomfort results

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Cleaning Instructions:

  • Remove the foam wedge from the nylon pack.
  • Hand wash the nylon pack in cold water with a mild detergent and allow to air dry.
  • Once dry, reinsert foam wedge and seal the Velcro closure.
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