Levels of recommendations (Standard, Guideline, and Option) and levels of evidence (I-V) are defined at the end of the "Major Recommendations" field.
Diagnosis
The presence or absence of obstructive sleep apnea (OSA) must be determined before initiating treatment with oral appliances to identify those patients at risk due to complications of sleep apnea and to provide a baseline to establish the effectiveness of subsequent treatment. Detailed diagnostic criteria for OSA are available and include clinical signs, symptoms, and the findings identified by polysomnography. The severity of sleep related respiratory problems must be established in order to make an appropriate treatment decision. (Standard)
This recommendation is the same recommendation as the recommendation of the previous practice parameter paper. However, there is a higher level of evidence that severity of OSA is predictive of response to oral appliances.
Appliance Fitting
Oral appliances should be fitted by qualified dental personnel who are trained and experienced in the overall care of oral health, the temporomandibular joint, dental occlusion, and associated oral structures. Dental management of patients with oral appliances should be overseen by practitioners who have undertaken serious training in sleep medicine and/or sleep related breathing disorders with focused emphasis on the proper protocol for diagnosis, treatment, and follow up. (Option)
This recommendation is a modification of the recommendation of the previous practice parameter paper to specify the training of the personnel responsible for fitting the oral appliances. It is based on committee consensus.
Although cephalometric evaluation is not always required for patients who will use an oral appliance, appropriately trained professionals should perform these examinations when they are deemed necessary (Option).
This recommendation is the same recommendation as the recommendation of the previous practice parameter paper.
Treatment
Treatment Objectives
For patients with primary snoring without features of OSA or upper-airway resistance syndrome, the treatment objective is to reduce the snoring to a subjectively acceptable level (Standard).
This recommendation is the same recommendation as the recommendation of the previous practice parameter paper.
For patients with OSA, the desired outcome of treatment includes the resolution of the clinical signs and symptoms of OSA and the normalization of the apnea-hypopnea index and oxyhemoglobin saturation (Standard).
This recommendation is the same recommendation as the recommendation of the previous practice parameter paper.
Oral appliances are appropriate for use in patients with primary snoring who do not respond to or are not appropriate candidates for treatment with behavioral measures such as weight loss or sleep-position change. (Guideline)
This recommendation is a modification of the recommendation of the previous practice parameter paper to exclude mild OSA patients; these latter patients are discussed in the next practice parameter. This recommendation is based on 1 level I study and 2 level V studies.
Although not as efficacious as continuous positive airway pressure (CPAP), oral appliances are indicated for use in patients with mild to moderate OSA who prefer oral appliances to CPAP, or who do not respond to CPAP, are not appropriate candidates for CPAP, or who fail treatment attempts with CPAP or treatment with behavioral measures such as weight loss or sleep-position change. (Guideline)
This is a new recommendation. It is based on 11 level I, 3 level II, and 16 level III-V studies that used stringent criteria for defining success.
Patients with severe OSA should have an initial trial of nasal CPAP because greater effectiveness has been shown with this intervention than with the use of oral appliances. Upper airway surgery (including tonsillectomy and adenoidectomy, craniofacial operations, and tracheostomy) may also supersede use of oral appliances in patients for whom these operations are predicted to be highly effective in treating sleep apnea. (Guideline)
This recommendation is a modification of the recommendation of the previous practice parameter paper to clarify treatment of patients with severe OSA. It is based on 1 level II study and 2 lower level studies.
Follow-up
Follow-up sleep testing is not indicated for patients with primary snoring. (Guideline)
This recommendation is the same recommendation as the recommendation of the previous practice parameter paper.
To ensure satisfactory therapeutic benefit from oral appliances, patients with OSA should undergo polysomnography or an attended cardiorespiratory (Type 3) sleep study with the oral appliance in place after final adjustments of fit have been performed. (Guideline)
This recommendation is a modification of the recommendation of the previous practice parameter paper to generalize therapeutic evaluation to all patients with OSA, not only patients with moderate to severe OSA. This recommendation is based on 2 level I and 5 level V studies. The reader is also referred to the recent practice parameter paper regarding indications for polysomnography (see National Guideline Clearinghouse [NGC] summary of American Academy of Sleep Medicine guideline Practice parameters for the indications for polysomnography and related procedures: an update for 2005.
Patients with OSA who are treated with oral appliances should return for follow-up office visits with the dental specialist. Once optimal fit is obtained and efficacy shown, dental specialist follow-up at every 6 months is recommended for the first year, and at least annually thereafter. The purpose of follow up is to monitor patient adherence, evaluate device deterioration or maladjustment, evaluate the health of the oral structures and integrity of the occlusion, and assess the patient for signs and symptoms of worsening OSA. Intolerance and improper use of the device are potential problems for patients using oral appliances, which require patient effort to use properly. Oral appliances may aggravate temporomandibular joint disease and may cause dental misalignment and discomfort that are unique to each device. In addition, oral appliances can be rendered ineffective by patient alteration of the device. (Option)
This recommendation is a modification of the recommendation of the previous practice parameter paper to generalize follow-up to all patients with OSA, to specify frequency of follow-up visits, and to expand upon the reasons for the follow-up visit. It is based upon committee consensus on factors described in the accompanying review paper.
Patients with OSA who are treated with oral appliances should return for periodic follow-up office visits with the referring clinician. The purpose of follow up is to assess the patient for signs and symptoms of worsening OSA. Close communication with the dental specialist is most conducive to good patient care. An objective reevaluation of respiration during sleep is indicated if signs or symptoms of OSA worsen or reoccur (Option)
This recommendation is a modification of the recommendation of the previous practice parameter paper to consolidate the reasons for follow-up with the referring clinician into a single practice parameter.
Definitions:
Levels of Recommendations
Standard: This is a generally accepted patient-care strategy, which reflects a high degree of clinical certainty. The term standard generally implies the use of Level I Evidence, which directly addresses the clinical issue, or overwhelming Level II Evidence.
Guideline: This is a patient-care strategy, which reflects a moderate degree of clinical certainty. The term guideline implies the use of Level II Evidence or a consensus of Level III Evidence.
Option: This is a patient-care strategy, which reflects uncertain clinical use. The term option implies either inconclusive or conflicting evidence or conflicting expert opinion.
Classification of Evidence
Level I (Grade A Recommendation): Randomized well-designed trials with low-alpha and low-beta errors*
Level II (Grade B Recommendation): Randomized trials with high-beta errors*
Level III (Grade C Recommendation): Nonrandomized controlled or concurrent cohort studies
Level IV (Grade C Recommendation): Nonrandomized historical cohort studies
Level V (Grade C Recommendation): Case series
*Alpha (type 1 error) refers to the probability that the null hypothesis is rejected when in fact it is true (generally acceptable at 5% or less, or p<0.05). Beta (Type II error) refers to the probability that the null hypothesis is mistakenly accepted when in fact it is false (generally trials accept a beta error of 0.20). The estimation of Type II error is generally the result of a power analysis. The power analysis takes into account the variability and the effect size to determine if sample size is adequate to find a difference in means when it is present (Power generally acceptable at 80-90%).
