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

Abstract

BackgroundOsteopathic 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.MethodsThis 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.ResultsTen 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.ConclusionsOsteopathic 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 registrationThe study was retrospectively registered in the clinicaltrial.gov registry under reference NCT01193738 on 1st September 2010 (first inclusion May 19, 2010).Electronic supplementary materialThe online version of this article (doi: 10.1186/s12906-017-2053-0) contains supplementary material, which is available to authorized users.

Osteopathic Manipulation of the Sphenopalatine Ganglia Versus Sham Manipulation, in Obstructive Sleep Apnoea Syndrom: A Randomised Controlled Trial

“…The first manipulation (active or sham) following randomisation was then administered. Correct application [ 11 ] of manipulation was verified by immediately evaluating lacrimation by Schirmer’s test [ 16 ] and pain experienced by the patient was assessed by a visual analogue scale. PNIF and awake Pcrit were measured again at 30 min.…”

“…AM and SM consisted of purely manual pressure, as described in Jacq et al [ 11 ]. Briefly, AM was performed successively on the right and left SPG, with the subject in the supine position, with the head turned towards the opposite side to that of the SPG to be manipulated.…”

“…Awake Pcrit was defined as the negative pressure required to induce upper airway obstruction and zero air flow. It was estimated experimentally according to a procedure identical to that described in the study by Jacq et al evaluating active SPG manipulation in OSAS patients [ 11 ]. Awake Pcrit has been validated for the evaluation of upper airway collapsibility in healthy subjects [ 22 ] and to assess the effect of mandibular advancement device in OSAS patients [ 23 ].…”

“…This finding has led to the recent emergence of personalised medicine [ 7 ] and phenotypic approaches to treatment [ 8 , 9 , 10 ]. In a pilot study, we showed that osteopathic manipulation of the sphenopalatine ganglia (SPG) can enhance upper airway stability in some OSAS patients [ 11 ]. In the light of these results, this technique warranted further investigation in the context of a personalised therapeutic approach to OSAS.…”

Mandibular advancement reveals long-term suppression of breathing discomfort in patients with obstructive sleep apnea syndrome

“…The airway pressure/flow relationship was established to determine the awake critical closing pressure (awake Pcrit), defined as the negative pressure that induces closure of the upper airways (absence of air flow). Awake Pcrit was determined while awake according to the method validated by Su et al (Su et al, 2008) and measured as described previously (Jacq et al, 2017;Patil et al, 2004;Schwartz et al, 1988;Su et al, 2009). The patients were installed in the supine position with the head resting in a neutral position on a flat pillow.…”