Effectiveness of transoral robotic surgery of the base of the tongue vs. conservative treatment for obstructive sleep apnea, a RCT, the RAPID study protocol

TL;DR

This study will compare transoral robotic surgery with non-surgical treatments for sleep apnea to determine which improves sleep and quality of life more effectively.

Contribution

The study introduces a randomized controlled trial to evaluate the effectiveness of transoral robotic surgery versus CPAP or MADs for moderate to severe obstructive sleep apnea.

Findings

The trial will assess outcomes like apnea hypopnea index and quality of life over 6 and 12 months.

It aims to provide evidence on whether surgery is superior to non-surgical therapies for sleep apnea.

Results will inform clinical guidelines and decision-making for obstructive sleep apnea treatment.

Abstract

CPAP is the gold standard treatment for obstructive sleep apnea (OSA) but suffers from poor long-term compliance. Alternatives like mandibular advancement devices (MADs) and surgery, such as transoral robotic surgery (TORS), are available, but their comparative efficacy is unclear.

This study aims to evaluate whether base of the tongue (BOT) reduction using TORS is equal or superior to CPAP and MADs in improving quality of sleep and life in patients with moderate to severe OSA eligible for surgery.

A prospective randomized controlled trial.

Patients eligible for TORS and CPAP or MAD aged >18 years with moderate to severe OSA (Apnea Hypopnea Index >15) untreated before.

In total 50 patients, 25 in each treatment arm will be randomized to either TORS or non-surgical therapy (CPAP or MAD depending on preference of patient or physician).

Primary outcomes will include improvement in sleep apnea severity measured through the apnea hypopnea index (AHI) and oxygen desaturation index (ODI)4%. Secondary outcomes will assess long-term quality of life compared to non-surgical therapy and adherence to devices.

The data will be analysed on an Intention-To-Treat principle (ITT). Ethical approval was obtained from RTPO in September of 2023. Trial registration number: NL84446.099.23 METCnumber UMCG25.327. Outcomes will be published in peer reviewed journals and presented at (inter)national conferences.

Findings of this study will address the evidence gap in the comparative effectiveness of TORS versus non-surgical therapies for OSA and may inform future clinical decision making and guideline development.

•There is currently insufficient evidence from RCTs regarding the efficacy of TORS compared to conservative treatment.•To address this gap, we propose conducting a trial to evaluate whether TORS offers superior outcomes compared to conservative treatment.•The primary endpoint is 6 month AHI, with 12 month follow up assessing durability.

There is currently insufficient evidence from RCTs regarding the efficacy of TORS compared to conservative treatment.

To address this gap, we propose conducting a trial to evaluate whether TORS offers superior outcomes compared to conservative treatment.

The primary endpoint is 6 month AHI, with 12 month follow up assessing durability.

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