Transoral robot surgery of the tongue base vs. Continuous positive airway pressure or mandibular advancement device as a treatment for moderate to severe obstructive sleep apnea.

In Obstructive Sleep Apnea (OSA) there is repeated partial or complete
obstruction of the upper airway, leading to hypoxia and fragmented sleep. OSA
is usually caused by multilevel collapse of the upper airway, with the tongue
base being the most common site of collapse. The prevalence is estimated to be
23,4% in women and 49,7% in men over the age of 40. Based on research by the
Apnea Association in 2015, the number of newly diagnosed OSA patients in the
Netherlands is estimated to be 40,785 per year. The overall prevalence of OSA
in the Netherlands is estimated to be 600,000 patients. OSA has a significant
effect on the overall health of patients. Hypertension, stroke, cardiovascular
disease, cognitive dysfunction, diabetes mellitus type 2 and arrhythmias are
much more common in patients with OSA. There is also an association between the
number of traffic accidents/deaths and OSA. The 5-year mortality rate of adults
with untreated OSA is increased by 30%. The gold standard treatment for OSA is
continuous positive airway pressure (CPAP). This is an effective treatment.
Nonetheless, 30% of patients refuse CPAP treatment. As it is generally accepted
that CPAP is only effective when used for more than 4 hours per night and in at
least 70% of nights, patient compliance remains a challenge. After 6 months, in
only 50% of the patients CPAP is used for more than 4 hours per night and after
5 years this percentage drops to only 17%. Secondary to CPAP are the mandibular
advancement devices (MAD) which move the mandible and or tongue ventrally which
opens the upper airway and reduces its collapsibility during sleep. Like CPAP,
the effectiveness of MAD depends on patient compliance. Surgery offers a great
advantage over conventional treatment as it offers the possibility to resolve
apneas and hypopneas and avoid lifelong use of CPAP or MAD without the problem
of poor patient compliance. Reduction of the tongue base via trans oral robotic
surgery (TORS) is an accepted and well tolerable treatment for OSA in patients
with collapse at tongue base site. The robot technique has shown to increase
surgical precision and more delicate handling of tissues. However, to this day,
it remains unclear if TORS has a higher efficacy compared to the non-surgical
gold standard CPAP and frequently used MAD. In addition, long-term effects of
TORS remain unclear. We hypothesize that TORS could be superior to conventional
treatment modalities in terms of improving sleep, overall health and quality of
life. Herewith, we present a research protocol for a prospective randomized
controlled trial that allows us to examine if tongue base reduction via TORS
has a superior outcome to the gold standard treatment CPAP and MAD in patients
with moderate to severe OSA.

The primary objective of this study is to objectify the efficacy of TORS
compared to CPAP and MAD.
Secondary objectives:
To determine long term outcomes of TORS compared to CPAP or MAD.
To compare functional sleep outcomes in TORS and CPAP/MAD patients.
To determine TORS surgical complications.
To evaluate health-related quality of life in both groups.
To assess the cost of TORS compared to CPAP and MAD.
To assess patient compliance of CPAP and MAD.
To evaluate post-operative pain after TORS.
To evaluate swallowing quality after TORS.

This study will be a randomized controlled trial.

Group 1 will contain 25 patients that will receive TORS as treatment of OSA.
Group 2 will contain 25 patients that will receive standard treatment via CPAP
or MAD depending on what patient and physician prefer.

Patients participating in this study will not impose any extra burden deviating
from the usual risks of standard care for OSA. Patients will visit the hospital
at 3 months, 6 months and 12 months for follow up and evaluation of treatment.
Study measurements will be collected during regular hospital visits. If
patients are randomized into the TORS group, they have the advantage of only
receiving one treatment compared to the conservative group, who will be treated
with CPAP or MAD every day over the course of the study. The disadvantage of
the TORS group is a chance of experiencing known complications associated with
surgery, such as bleeding and infections, which may result in a longer
post-surgery hospital stay. Furthermore, 3 quality of life, 1 sleep
questionnaire and 1 swallowing quality questionnaire are taken and are short so
will not impose a substantial burden on patients. As TORS as well as CPAP and
MAD are approved treatment modalities, there are no advantages over standard
care. Study participation will no longer enable patient and physician to choose
the treatment modality at first as it will be chosen through randomization.
However, after study participation, all treatment options are available when
indicated. Patients will not receive compensation for participating in the
study. No extra hospital visits are required to participate in the study.