Name of the Procedure:

Custom Fabricated Oral Device/Appliance to Reduce Upper Airway Collapsibility (E0486)

Summary

This procedure involves creating a custom-fitted oral device designed to keep the upper airway open during sleep. It's commonly used to treat conditions like obstructive sleep apnea (OSA), where the airway can become blocked, leading to disrupted breathing.

Purpose

Medical Conditions Addressed:

• Obstructive Sleep Apnea (OSA)
• Snoring
• Mild to Moderate Sleep Apnea

Goals:

• To prevent airway collapse during sleep
• To improve breathing quality
• To reduce symptoms such as daytime sleepiness, snoring, and poor sleep quality

Indications

Symptoms or Conditions:

• Loud, chronic snoring
• Periods of stopped breathing during sleep (observed by a partner)
• Excessive daytime sleepiness
• Mood changes and fatigue

Patient Criteria:

• Diagnosed with OSA by a sleep study
• Patients who cannot tolerate CPAP (Continuous Positive Airway Pressure)
• Those with mild to moderate OSA as recommended by a physician

Preparation

• Diagnosis Confirmation: Sleep study (Polysomnography)
• Fitting Appointment: A dental impression or digital scan of the teeth and gums
• Pre-Procedure Instructions: No special preparation like fasting, but maintaining good oral hygiene is essential

Procedure Description

1. Assessment: Initial consultation with a dentist or sleep specialist.
2. Impression: Dental impressions or digital scans are taken to create a custom-fit oral appliance.
3. Fabrication: The device is custom-made in a dental lab.
4. Fitting: The patient returns for a fitting appointment where the device is adjusted for comfort and efficacy.
5. Adjustment: Follow-up visits may be required to fine-tune the fit and positioning of the device.

Tools and Equipment:

• Dental impression materials or digital scanners
• Custom manufacturing tools

Anesthesia:

• None required, unless any previous dental work is needed before fitting.

Duration

• Initial fitting and impression: 30 minutes to 1 hour
• Subsequent fitting and adjustments: 15-30 minutes

Setting

• Outpatient clinic or dental office

Personnel

• Dentist specialized in sleep medicine
• Dental assistant
• Sleep specialist (if needed for further consultation)

Risks and Complications

Common Risks:

• Discomfort in the mouth and jaw
• Salivation changes (increase or decrease)
• Temporary bite changes

Rare Complications:

• Temporomandibular joint (TMJ) discomfort
• Long-term bite changes if not properly adjusted or monitored

Benefits

Expected Outcomes:

• Improved breathing during sleep
• Reduction or elimination of snoring
• Enhanced sleep quality and reduced daytime sleepiness
• Symptom relief can often be noticed within days of starting to use the device

Recovery

• Minimal recovery time
• Patient may experience initial discomfort that typically resolves over days to weeks
• Regular follow-up appointments to ensure optimal fit and function

Alternatives

CPAP (Continuous Positive Airway Pressure):

• More effective for severe OSA, but can be uncomfortable for some patients ##### Lifestyle Changes:
• Weight loss, positional therapy, avoiding alcohol and smoking ##### Surgical Options:
• For severe cases where other treatments are ineffective

Patient Experience

• During fitting, the patient may feel slight pressure or discomfort which is generally mild.
• After the procedure, patients may feel initial discomfort as they adapt to wearing the device.
• Pain management typically involves over-the-counter pain relievers, if needed.
• Patients are encouraged to communicate any discomfort or issues so adjustments can be made promptly.