Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study

Olivier Jacq, Isabelle Arnulf, Thomas Similowski, Valérie Attali, Olivier Jacq, Isabelle Arnulf, Thomas Similowski, Valérie Attali

Abstract

Background: Osteopathic manipulative treatment (OMT) of the sphenopalatine ganglion (SPG) is used empirically for the treatment of rhinitis and snoring and is thought to increase pharyngeal stability. This trial was designed to study the effects of this treatment on pharyngeal stability evaluated by critical closing pressure in obstructive sleep apnoea syndrome.

Methods: This single-centre, randomized, crossover, double-blind study compared active manipulation and sham manipulation of the SPG. Randomization was computer-generated. Patients each received one active manipulation and one sham manipulation at an interval of 21 days and were evaluated 30 min and 48 h after each session administered by a qualified osteopath. Neither the patients, nor the investigator performing the evaluations were informed about the order of the two techniques (double-blind). The primary endpoint was the percentage of responding patients presenting increased pharyngeal stability defined by a variation of critical closing pressure (Pcrit) of at least -4 cmH2O at 30 min. Secondary endpoints were the variation of Pcrit in absolute values, sleepiness and snoring. Others endpoints were lacrimation (Schirmer's test), induced pain, sensations experienced during OMT.

Results: Ten patients were included and nine (57 [50; 58] years, comprising 7 men, with an apnoea-hypopnoea index of 31.0 [25.5; 33.2]/h; (values are median [quartiles])) were analysed. Seven patients were analysed for the primary endpoint and nine patients were analysed for secondary endpoints. Five patients responded after active manipulation versus no patients after sham manipulation (p = 0.0209). Active manipulation induced more intense pain (p = 0.0089), increased lacrimation (ns) and more tactile, nociceptive and gustatory sensations (13 versus 1) compared to sham manipulation. No significant difference was observed for the other endpoints.

Conclusions: Osteopathic manipulative treatment of the SPG may improve pharyngeal stability in obstructive sleep apnoea syndrome. This trial validates the feasibility of the randomized, controlled, double-blind methodology for evaluation of this osteopathic treatment. Studies on a larger sample size must specify the efficacy on the apnoea-hypopnoea index.

Trial registration: The study was retrospectively registered in the clinicaltrial.gov registry under reference NCT01193738 on 1st September 2010 (first inclusion May 19, 2010).

Keywords: Critical closing pressure; Intraoral manipulation; Obstructive sleep apnoea; Osteopathic manipulative treatment; Sphenopalatine ganglion.

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the Comittee for the Protection of Human Research Participants, Paris VI (Comité de Protection des Personnes Ile-de-France VI, Paris, France) (IEC/IRB). Patients were informed and gave their written consent to participate.

Consent for publication

Not applicable

Competing interests

Mr. Olivier Jacq declares no competing interests.

Dr. Isabelle Arnulf reports: Speakers’ Bureau for UCB: not related to the study.

Dr. Thomas Similowski reports personal fees from AstraZeneca, Boehringer Ingelheim France, GlaxoSmithKline France, Invacare, Mundipharma, Teva Pharma, Lungpacer Inc., Pierre Fabre Médicaments; personal fees and nonfinancial support from Novartis France, grants from Covidien, Phillips, grants and other funding from Air Liquide Medical Systems. None of the above is related to the study.

Dr. Valérie Attali reports: investigational device for Somnomed, Resmed and Imthera; grant/research Support from Resmed to Pitié-Salpêtrière hospital (no fees to V Attali); and consultant for Nyxoah. None of the above is related to the study.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart
Fig. 2
Fig. 2
a, b, c Intraoral myofascial therapy of the sphenopalatine ganglion. Position of the patient’s head and the osteopath’s fifth finger, during SPG release
Fig. 3
Fig. 3
Upper airway critical closing pressure (Pcrit) before, 30 min and 48 h after sham manipulation (SM) (left) and active manipulation (AM) (right) of the sphenopalatine ganglion. The box represents the Q1-Q3 interquartile range, in which Q1 represents the first quartile and Q3 represents the third quartile. The bar in the box represents the median. The endpoint of the lower whisker is the minimum value higher than the lower limit defined by the following formula: Q1-1.5* (Q3-Q1). The endpoint of the upper whisker is the maximum value lower than the upper limit defined by the following formula: Q3 + 1.5* (Q3-Q1). + represent individual values

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