The alternatives for treating obstructive sleep apnea (OSA) to date have been limited.
Continuous Positive Airway Pressure (CPAP) therapy has been the gold standard and still remains the foundation of the therapeutic approach to the patient with sleep-disordered breathing.1 However, recent data show that only 50% of patients initiated on CPAP therapy are considered compliant.2
Fortunately, other options have been developed for those who cannot, or will not, use CPAP therapy..
Oral mandibular advancing dental appliances have been proven to be an effective mode of therapy for some, for example. Advances in otolaryngological surgery have also proven to be of some benefit; but for most, the surgical options are not curative for obstructive respirations.
In this era of innovation there is now an implantable, FDA-approved upper airway stimulation device that, in the correct patient population, demonstrates significant and sustained improvements in patient outcomes.
In this article, we will review therapeutic options for OSA patients who struggle with CPAP with particular emphasis on the new upper airway stimulation treatment.
Positive Airway Pressure
PAP therapy has long been, and still is, the most frequently prescribed in the treatment of sleep apnea. For predominantly obstructive respirations, this would encompass CPAP and Bilevel PAP (BiPAP).
Features have been added to PAP units in order to make the use of the therapy more tolerable. These features include heated humidification, heated in-line tubing, pressure relief systems, and auto titrating units. Respiratory therapy as follow-up is also beneficial.3
If successful therapy has not been achieved; consideration for a PAP NAP would be indicated. This is a limited in-laboratory study scheduled during the daytime; the patient is interacting one-on-one with laboratory staff to achieve comfortable settings and comfortable interface.4
SEE ALSO: CPAP Compliance Improves Outcomes
Oral appliances can also be an effective form of therapy for OSA patients. They are indicated in mild to moderate OSA patients who have failed CPAP.5 It is recommended that the patient undergo evaluation with a dentist who regularly uses these devices, and has experience with multiple types of devices, so that a choice can be made as to the most effective and comfortable device.
An important adjunct in treating OSA is behavioral therapy. Weight loss for those with a BMI >25 can improve, and possibly cure, the underlying obstructive respirations. For those patients with a BMI >40 or >35 with co-morbidities, bariatric surgery should be discussed as a possible approach to weight loss.
Positional therapy is targeted at keeping the patient in the non-supine position. This can be in addition to other forms of therapy or in some cases as sole therapy if the apneic episodes are only in the supine position. If used as sole therapy, repeat testing in the supine position would be indicated.6
Surgical intervention can also be considered for the treatment of obstructive sleep apnea where success is measured as reduction in severity of apnea, not necessarily an elimination of apnea. The most common of these surgical interventions include: septoplasty, tonsillectomy and adenoidectomy, uvulopalatopharyngealplasty, genioglossal advancement, hyoid suspension and maxillomandibular advancement.7
Upper Airway Stimulation
Now, there is a new option for moderate to severe OSA patients who are not able to use CPAP. Inspire Upper Airway Stimulation therapy is an implantable device to add to our arsenal of OSA therapies.
The concept behind Inspire therapy is that during the process of airway obstruction there is decreased tone in the muscles of the upper airway. The Inspire device delivers mild stimulation to key airway muscles via the hypoglossal nerve. This mild stimulation can restore strength and tone to upper airway muscles and prevent the airway from collapsing during sleep.
Unilateral stimulation of the hypoglossal nerve was shown to be a safe and effective means of treatment in the STAR clinical trial. The STAR Trial was a multicenter, prospective, single arm cohort study with 126 patients. The upper airway stimulation device was implanted in patients with moderate to severe apnea who failed use of PAP therapy. Primary outcome measures were published in the Jan. 9, 2014, edition of the New England Journal of Medicine.8 These primary outcome measures included:
- Apnea Hypopnea Index (AHI) showing a 68% reduction
- Oxygen Desaturation Index (ODI) showing a 70% reduction
- Epworth Sleepiness Scale (ESS) showing improvement and normalization
- Functional Outcomes of Sleep (FOSQ) showing improvement and normalization.
- Procedure-related serious adverse events rate of < 2%
The Inspire device is a small implant that is inserted under the skin in the upper chest. A sensing lead is placed at the fourth intercostal space to sense respirations and the stimulation lead is placed at the medial branch of the hypoglossal nerve. Mild stimulation of the hypoglossal nerve gently moves the tongue forward to open the airway during sleep. A patient uses a sleep remote to turn the device on when they go to bed and off in the morning when they wake up.
In April 2014, the FDA approved Inspire therapy for the treatment of OSA. Current recommendations in considering a patient for implantation include:
- PAP failure (unable to use or accept PAP therapy)
- BMI of < 32
- AHI 20-65 (no greater than 25% central events) on full night polysomnography
- An anatomy assessment that would be consistent with successful use of the device
- Medically stable
In November, 2015, the STAR trial three-year, long-term outcomes data was published in Otolaryngology - Head and Neck Surgery, the official peer-reviewed publication of the American Academy of Otolaryngology - Head and Neck Surgery Foundation.9
The new long-term study outcomes showed that the improvements observed at one-year were sustained at the three-year follow up mark. The outcomes include:
- A 78% reduction in apnea-hypopnea index (AHI) from baseline
- An 80% reduction in oxygen desaturation events from baseline
- 80% of bed partners reported soft or no snoring as compared to 17% of bed partners at baseline
- Quality of life measures, including daytime sleepiness and functioning, showed clinically meaningful improvements and a return to normal levels over baseline
Front Row Seat
My personal experience to date is that we have an effective new tool at our disposal for the treatment of moderate to severe sleep apnea. It does require a meticulous history and conversation with the patient to determine whether or not they are PAP intolerant. The vast majority of patients seen in our follow-up clinic have not had an effective discussion on alternatives to CPAP therapy.
Although upper airway stimulation is most often used as a standalone therapy, it can also be used in conjunction with other modalities such as weight loss and positional therapy. The view needs to be one of long-term management of this patient population and the needs may change throughout the course of their lives.
1.Epstein, LJ, Kristo, D et al (2009) Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults J of Clin Sleep Medicine 5(3) 263-276.
2.Sawyer AM, Gooneratne, N. et al(2011). a systematic of CPAP adherence across age groups: clinical and empirical insights for developing CPAP adherence interventions. Sleep Med Rev, 343-356.
3.Ballard RD, Gay PC, Strollo PJ. (2007) Interventions to improve compliance in sleep apnea patients previously non-compliant with continuous positive airway pressure. J Clin Sleep Med 3(7):706-712.
4. Krakow B, Ulibarri V, et al (2008) A daytime, abbreviated cardio-respiratory sleep study (CPT 95807-52) to acclimate insomnia patients with sleep-disordered breathing to positive airway pressure (PAP-NAP). J Clin Sleep Medicine 4(3):212-22
5. Kushida CA, Morgenthaler, T. et al (2005) Practice parameters for the treatment of snoring and obstructive sleep apnea with oral appliances: an update for 2005. Sleep
6. Morgenthaler, T, Kapen, S, et al (2009) Practice parameters for the medical treatment of obstructive sleep apnea. Sleep 28(8)1031-1034
7. Caples SM, Rowley JA, Prinsell JR, et al. (2010)Surgical modifications of the upperairway for obstructive sleep apnea in adults: a systematic review and meta-analysis. Sleep 33:1396-407.
8. Strollo, PJ, Soose, R. et al (2014). Upper-Airway Stimulation for Obstructive Sleep Apnea. New England Journal of Medicine, 139-149.
9. Woodson BT1, S. R., & Investigators., S. T. (2016). Three-Year Outcomes of Cranial Otolaryngol Head Neck Surg, 181-188.
Dr. Colleen G. Lance is assistant professor of medicine, University Hospitals, Case Medical Center, Cleveland.