Effect of Upper Airway Stimulation in Patients With Obstructive Sleep Apnoea (EFFECT): A Randomized Controlled Crossover Trial

Background: Several single-arm prospective studies have demonstrated the safety and effectiveness of upper airway stimulation (UAS) for obstructive sleep apnea. There is limited evidence from randomized, controlled trials of the therapy benefit in terms of OSA burden and its symptoms. Methods: We conducted a multicenter, double-blinded, randomized, sham-controlled, crossover trial to examine the effect of therapeutic stimulation (Stim) versus sham stimulation (Sham) on the apnea-hypopnea index (AHI) and the Epworth Sleepiness Scale (ESS). We also examined the Functional Outcomes of Sleep Questionnaire (FOSQ) on sleep architecture. We analyzed crossover outcome measures after two weeks using repeated measures models controlling for treatment order. Results: The study randomized 89 participants 1:1 to Stim (45) versus Sham (44). After one week, the AHI response rate was 76.7% with Stim and 29.5% with Sham, a difference of 47.2% (95% CI: 24.4 to 64.9, p < 0.001) between the two groups. Similarly, ESS was 7.5 ± 4.9 with Stim and 12.0 ± 4.3 with Sham, with a significant difference of 4.6 (95% CI: 3.1 to 6.1) between the two groups. The crossover phase showed no carryover effect. Among 86 participants who completed both phases, the treatment difference between Stim vs. Sham for AHI was −15.5 (95% CI −18.3 to −12.8), for ESS it was −3.3 (95% CI −4.4 to −2.2), and for FOSQ it was 2.1 (95% CI 1.4 to 2.8). UAS effectively treated both REM and NREM sleep disordered breathing. Conclusions: In comparison with sham stimulation, therapeutic UAS reduced OSA severity, sleepiness symptoms, and improved quality of life among participants with moderate-to-severe OSA.

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Effect of upper-airway stimulation for obstructive sleep apnoea on airway dimensions

European Respiratory Journal ◽

10.1183/09031936.00059414 ◽

2014 ◽

Vol 45 (1) ◽

pp. 129-138 ◽

Cited By ~ 78

Author(s):

Faiza Safiruddin ◽

Olivier M. Vanderveken ◽

Nico de Vries ◽

Joachim T. Maurer ◽

Kent Lee ◽

...

Keyword(s):

Obstructive Sleep Apnoea ◽

Hypoglossal Nerve ◽

Upper Airway ◽

Sleep Apnoea ◽

Therapeutic Level ◽

Drug Induced ◽

Upper Airway Stimulation ◽

Cross Sectional ◽

Obstructive Sleep ◽

Anterior Posterior

Upper-airway stimulation (UAS) using a unilateral implantable neurostimulator for the hypoglossal nerve is an effective therapy for obstructive sleep apnoea patients with continuous positive airway pressure intolerance. This study evaluated stimulation effects on retropalatal and retrolingual dimensions during drug-induced sedation compared with wakefulness to assess mechanistic relationships in response to UAS.Patients with an implanted stimulator underwent nasal video endoscopy while awake and/or during drug-induced sedation in the supine position. The cross-sectional area, anterior–posterior and lateral dimensions of the retropalatal and retrolingual regions were measured during baseline and stimulation.15 patients underwent endoscopy while awake and 12 underwent drug-induced sedation endoscopy. Increased levels of stimulation were associated with increased area of both the retropalatal and retrolingual regions. During wakefulness, a therapeutic level of stimulation increased the retropalatal area by 56.4% (p=0.002) and retrolingual area by 184.1% (p=0.006). During stimulation, the retropalatal area enlarged in the anterior–posterior dimension while retrolingual area enlarged in both anterior–posterior and lateral dimensions. During drug-induced sedation endoscopy, the same stimulation increased the retropalatal area by 180.0% (p=0.002) and retrolingual area by 130.1% (p=0.008). Therapy responders had larger retropalatal enlargement with stimulation than nonresponders.UAS increases both the retropalatal and retrolingual areas. This multilevel enlargement may explain reductions of the apnoea–hypopnoea index in selected patients receiving this therapy.

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Short-term results of upper airway stimulation in obstructive sleep apnoea patients: the Amsterdam experience

The Journal of Laryngology & Otology ◽

10.1017/s0022215120000961 ◽

2020 ◽

Vol 134 (5) ◽

pp. 447-452

Author(s):

P E Vonk ◽

M J L Ravesloot ◽

J P van Maanen ◽

N de Vries

Keyword(s):

Obstructive Sleep Apnoea ◽

Upper Airway ◽

Sleep Apnoea ◽

Consecutive Series ◽

Short Term ◽

Drug Induced ◽

Upper Airway Stimulation ◽

Surgical Success ◽

Obstructive Sleep ◽

Significant Difference

AbstractObjectivesThis paper aimed to: retrospectively analyse single-centre results in terms of surgical success, respiratory outcomes and adverse events after short-term follow up in obstructive sleep apnoea patients treated with upper airway stimulation; and evaluate the correlation between pre-operative drug-induced sleep endoscopy findings and surgical success.MethodsA retrospective descriptive cohort study was conducted, including a consecutive series of obstructive sleep apnoea patients undergoing implantation of an upper airway stimulation system.ResultsForty-four patients were included. The total median Apnoea–Hypopnea Index and oxygen desaturation index significantly decreased from 37.6 to 8.3 events per hour (p < 0.001) and from 37.1 to 15.9 events per hour (p < 0.001), respectively. The surgical success rate was 88.6 per cent, and did not significantly differ between patients with or without complete collapse at the retropalatal level (p = 0.784). The most common therapy-related adverse event reported was (temporary) stimulation-related discomfort.ConclusionUpper airway stimulation is an effective and safe treatment in obstructive sleep apnoea patients with continuous positive airway pressure intolerance or failure. There was no significant difference in surgical outcome between patients with tongue base collapse with or without complete anteroposterior collapse at the level of the palate.

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Changes in the calibre of the upper airway and the surrounding structures after maxillomandibular advancement for obstructive sleep apnoea

British Journal of Oral and Maxillofacial Surgery ◽

10.1016/j.bjoms.2014.02.006 ◽

2014 ◽

Vol 52 (5) ◽

pp. 445-451 ◽

Cited By ~ 32

Author(s):

Yuh-Jia Hsieh ◽

Yu-Fang Liao ◽

Ning-Hung Chen ◽

Yu-Ray Chen

Keyword(s):

Obstructive Sleep Apnoea ◽

Upper Airway ◽

Sleep Apnoea ◽

Maxillomandibular Advancement ◽

Obstructive Sleep

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Desipramine improves upper airway collapsibility and reduces OSA severity in patients with minimal muscle compensation

European Respiratory Journal ◽

10.1183/13993003.00823-2016 ◽

2016 ◽

Vol 48 (5) ◽

pp. 1340-1350 ◽

Cited By ~ 40

Author(s):

Luigi Taranto-Montemurro ◽

Scott A. Sands ◽

Bradley A. Edwards ◽

Ali Azarbarzin ◽

Melania Marques ◽

...

Keyword(s):

Crossover Trial ◽

Positive Airway Pressure ◽

Upper Airway ◽

Sleep Apnoea ◽

Double Blind ◽

Healthy Humans ◽

Dilator Muscle ◽

Obstructive Sleep ◽

Airway Collapsibility ◽

Upper Airway Collapsibility

We recently demonstrated that desipramine reduces the sleep-related loss of upper airway dilator muscle activity and reduces pharyngeal collapsibility in healthy humans without obstructive sleep apnoea (OSA). The aim of the present physiological study was to determine the effects of desipramine on upper airway collapsibility and apnoea–hypopnea index (AHI) in OSA patients.A placebo-controlled, double-blind, randomised crossover trial in 14 OSA patients was performed. Participants received treatment or placebo in randomised order before sleep. Pharyngeal collapsibility (critical collapsing pressure of the upper airway (Pcrit)) and ventilation under both passive (V′0,passive) and active (V′0,active) upper airway muscle conditions were evaluated with continuous positive airway pressure (CPAP) manipulation. AHI was quantified off CPAP.Desipramine reduced activePcrit(median (interquartile range) −5.2 (4.3) cmH2O on desipramineversus−1.9 (2.7) cmH2O on placebo; p=0.049) but not passivePcrit(−2.2 (3.4)versus−0.7 (2.1) cmH2O; p=0.135). A greater reduction in AHI occurred in those with minimal muscle compensation (defined asV′0,active−V′0,passive) on placebo (r=0.71, p=0.009). The reduction in AHI was driven by the improvement in muscle compensation (r=0.72, p=0.009).In OSA patients, noradrenergic stimulation with desipramine improves pharyngeal collapsibility and may be an effective treatment in patients with minimal upper airway muscle compensation.

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