Abstract: BACKGROUND: Obstructive sleep apnea (OSA) frequently coexists with headaches, with the relationship between the two disorders not fully elucidated. The Vivos Complete Airway Repositioning and/or Expansion (CARE) Systems are the Food and Drug Administration-approved removable oral appliances for maxillary expansion, mandibular advancement, and treatment of OSA. OBJECTIVE: This study aimed to assess the impact of Vivos CARE Systems on headache burden in nonclassified headache types in patients with OSA. METHODS: This retrospective pre- and posttreatment study used anonymized data from 114 patients with OSA who used one of two Vivos devices (the daytime–nighttime appliance and the mandibular repositioning nighttime appliance). RESULTS: Posttreatment, the mean Headache Impact Test-6 (HIT-6) score significantly reduced from 55.6 (44.5–62) to 43.9 (36.0–48.5) ( P < 0.001), indicating a decreased headache impact from substantial to little or none. About 61% of patients showed an improvement in their categorical HIT-6 score, and the percentage of patients in the population whose headache impact was substantial or severe decreased from 49.1% to 12.7%. The average time difference between the headache impact questionnaires was 477 days, with a median of 378 days. Fifty-five patients completed before and after sleep studies without the appliances in place to evaluate OSA severity. There was no improvement in OSA severity, although the study was not powered to evaluate the change in OSA severity. The average time difference between the sleep studies was 652 days, with a median of 443 days. CONCLUSIONS: These results suggest the potential efficacy of maxillary expansion and mandibular advancement devices in reducing headache impact as measured by the HIT-6 score. The minimal reduction in AHI in the previous study and no reduction in AHI in the present study could imply a different underlying mechanism, possibly associated with device-induced structural changes. However, the limitations, including the lack of data on specific headache disorders and reliance on HIT-6 as a composite headache metric, warrant further investigation, ideally based on randomized controlled trials, to clarify the specific anatomical traits influencing this outcome.
Li et al. (2026) studied this question.