dreamTAP Overview Video

Introduction ¶ 

The dreamTAPTM is an oral device intended to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA).

The dreamTAPTM device consists of an Upper Tray that fits over the upper teeth. A hook mechanism attached to the Lower Tray fits onto a bar attached to the Upper Tray and positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. The Adjustment Key of the dreamTAPTM permits the patient to adjust the protrusion of his/her lower jaw to the most effective and comfortable position.

Block Image

The dreamTAPTM is supplied with a bar that is larger than the opening of the hook, preventing the appliances from disengaging. The bar contains a small, flat area that will allow engagement of the hook.

Linings: The device is fabricated on the dental casts of the individual patients. The dreamTAP has many different tray and lining options. Refer to the separate instructions for more information.

Each dreamTAPTM package contains:

  1. An Upper and Lower Tray
  2. Instructions for Use
  3. Storage Case
  4. AM Alinger
  5. Adjustment Key
  6. 2 Additional Hooks

Indications ¶ 

The dreamTAPTM (Thornton Adjustable Positioner) is intended to reduce or alleviate nighttime snoring and sleep related breathing disorders including obstructive sleep apnea (OSA). The appliance is for adult patients to be used when sleeping at home or in a sleep laboratory and is for single patient use.

Contraindications ¶ 

This device is contraindicated for patients with loose teeth, loose dental work, dentures, or other oral conditions which would be adversely affected by wearing dental appliances. In addition, the appliance is contraindicated for patients who have central sleep apnea, have severe respiratory disorders or who are under 18 years of age.

Warnings ¶ 

  • This device is intended to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA). If symptoms, breathing difficulties or other respiratory disorders exist or persist, with or without the device, the patient should contact the prescriber immediately.
  • The dreamTAPTM should only be used as directed. Do NOT misuse the product.
  • You may experience soreness or discomfort in your jaw or teeth. If discomfort persists, you should contact the prescriber.
  • In the morning, you may sense a change in your bite. This change should disappear as the day progresses. If it continues with no change, you should contact the prescriber.
  • US Federal Law restricts this device to sale by prescription only
  • Do NOT use if you have braces
  • Do NOT use if you have not seen a dentist in the last 12 months or are under active treatment
  • Do NOT use if you have loose teeth, loose crowns or loose fillings.
  • Do NOT use if you have temporary crowns, removable dentures, or bridges.
  • You may experience obstruction of oral breathing with any oral appliance in the mouth.
  • Do not store or transport the dreamTAP outside the temperature range of -4oF to 122oF (-20oC to 50oC)
  • You must have at least 8 natural, healthy teeth in each arch.
  • In the event of muscle or jaw joint pain, discontinue use for a minimum of two days or until pain subsides and consult the prescriber.
  • Discontinue use if experience discomfort and consult the prescriber
  • Do NOT use the dreamTAPTM if vomiting or feeling nauseous.
  • Do NOT use if the patient cannot remove the product themselves.
  • You should return to the prescriber at least yearly, or as often as necessary for re-evaluation. If the dreamTAPTM is lined with ThermAcrylTM, the lining should be replaced yearly.
  • If the appliance becomes loose, damaged or does not fit properly, contact the prescriber.
  • Do NOT wash the dreamTAP TM in the dishwasher or use dishwashing liquid to wash the dreamTAP TM.
  • Do NOT clean the dreamTAP TM with products that contain chlorine, bleach, moisturizer, antiseptic, anti-bacterial agents or alcohol.
  • Do NOT store the dreamTAP TM in direct sunlight.
  • The operating temperature range of the dreamTAP TM is 40oF to 104oF (5oC to 40oC).
  • For use by adults only (>66 lb / 30 kg)
  • Discontinue use if the dreamTAP TM is damaged or cracked
  • Allergic reactions may be encountered. Discontinue use if reaction occurs and consult prescriber.

Possible Side Effects ¶ 

There are possible side effects associated with using the dreamTAP TM appliance. These side effects are not uncommon. If you experience any of the following side effects, you should contact your prescriber immediately.

  • Slight tooth or gingival discomfort due to pressure of the appliance.
  • Excess salivation initially. This will improve as you become accustomed to wearing the dreamTAP TM.
  • Slight jaw soreness or tightness, initially and with adjustments.
  • Temporary bite change. This will subside approximately 30 minutes after the dreamTAP TM is taken out of the mouth in the morning and the AM Aligner is used.
  • Unconsciously taking the dreamTAP TM out of his/her mouth at night.
  • Movement of the teeth.
  • Pain in the jaw joint.
  • Permanent bite change.

Airway Management Contacts ¶ 

Manufacturer:

Airway Management

3418 Midcourt Rd. Suite 114

Carrollton, TX 75006

Tel: (866) 264-7667

Fax: (214) 691-3151

email: contactami@amisleep.com

website: www.tapintosleep.com

United States and Canada:

Airway Management

(866) 264-7667

(214) 691-3151

contactami@amisleep.com

EU Authorized Representative:

Cyton Bioscience Ltd

68 Macrae Road

Eden Office Park

Ham Green

Bristol

BS020 0DD

United Kingdom