Outcome Reporting in Prospective Studies Evaluating Neurostimulation for Obstructive Sleep Apnea

Area of Science:

• Sleep Medicine
• Neuroscience
• Medical Devices

Background:

• Unilateral hypoglossal nerve stimulation is an emerging treatment for obstructive sleep apnea.
• The appropriate outcome measures for neurostimulation therapies remain debated.
• Standardized reporting of polysomnography and apnea-hypopnea index (AHI) is lacking in current research.

Purpose of the Study:

• To systematically describe the reporting methods of polysomnography and AHI in prospective studies of unilateral hypoglossal nerve stimulation.
• To identify variability and inconsistencies in outcome reporting for this neurostimulation technique.

Main Methods:

• A systematic literature search was conducted across MEDLINE, Embase, Cochrane Library, and Scopus.
• Studies were screened and assessed for quality following PRISMA guidelines using the Newcastle-Ottawa Scale or Covidence risk-of-bias tool.
• Fifteen prospective studies (14 cohort, 1 RCT) met the inclusion criteria.

Main Results:

• Polysomnography methods varied, with titration polysomnography used in five studies and non-titration in three.
• Three studies combined data from multiple sleep studies to report a single AHI.
• Non-titration AHI was the most frequently reported (five studies), while titration AHI was used in only one study; five studies did not specify the AHI type.

Conclusions:

• Significant heterogeneity exists in the reporting of sleep studies and AHI in unilateral hypoglossal nerve stimulation research.
• Consistent use of a standardized AHI is recommended for future studies to improve outcome comparability.
• Standardization will enhance the interpretation of treatment effectiveness for hypoglossal nerve stimulation.