Randomized Crossover Trial of Two Treatments for Sleep Apnea/Hypopnea Syndrome

Abstract

Mandibular repositioning splints (MRSs) and continuous positive airway pressure (CPAP) are used to treat the sleep apnea/hypopnea syndrome (SAHS). There are some data suggesting that patients with milder symptoms prefer MRS, but there are few comparative data on outcomes. Therefore, we performed a randomized crossover trial of 8 weeks of CPAP and 8 weeks of MRS treatment in consecutive new outpatients diagnosed with SAHS (apnea/hypopnea index [AHI] >or= 5/hour, and >or= 2 symptoms including sleepiness). Assessments at the end of both limbs comprised home sleep study, subjective ratings of treatment value, sleepiness, symptoms, and well-being, and objective tests of sleepiness and cognition. Forty-eight of 51 recruited patients completed the trial (12 women; age [mean +/- SD], 46 +/- 9 years; Epworth 14 +/- 4; median AHI, 22/hour; interquartile ratio [IQR], 11-43/hour). Significant (p <or= 0.01) differences between MRS and CPAP were observed for 7 of 21 variables (effect sizes, 0.3-0.6 SDs), all favoring CPAP, including AHI (15 +/- 16 and 8 +/- 6/hour, respectively), effectiveness rating, symptoms, Epworth (12 +/- 5 and 8 +/- 5, respectively), functional outcomes of sleepiness questionnaire, short-form 36 health survey mental component, and health transition scores. Objective sleepiness, cognitive performance, and preference for treatments were not different. In patients experiencing a mild form of the syndrome (AHI < 15, n = 18), symptoms, treatment efficacy and satisfaction, and subjective sleepiness were also better with CPAP than with MRS (effect sizes, 0.7-1.1 SDs). These results do not support these MRS devices as first-line treatment for sleepy patients with SAHS.

Controlled, prospective trial of psychosocial function before and after continuous positive airway pressure therapy

“…Its findings corroborated those of previous controlled trials [11][12][13][14][15][16][17] of improved SF-36 and Epworth scores after CPAP, and showed for the first time in a controlled setting additional improvements in marital satisfaction [18] and sleepiness-related functional status [5].…”

“…Symptoms of the sleep apnoea/hypopnoea syndrome (SAHS) impact on many aspects of the daily behaviour and function of a patient, affecting marital and family relationships [1][2][3], work efficiency and income [1,4], activity level [4][5][6][7] and general health and functional status [5,[8][9][10][11][12][13][14][15][16][17]. Controlled, prospective clinical trials employing validated psychosocial outcomes [12][13][14][15][16][17] have documented improvements in sleepiness and general health/functional status after continuous positive airway pressure (CPAP) therapy, but there have been no prospective controlled trials of changes in marital satisfaction. Quantitative comparisons of the magnitude of therapeutic effects across these related psychosocial areas are scanty.…”

“…Controlled, prospective clinical trials employing validated psychosocial outcomes [12][13][14][15][16][17] have documented improvements in sleepiness and general health/functional status after continuous positive airway pressure (CPAP) therapy, but there have been no prospective controlled trials of changes in marital satisfaction. Quantitative comparisons of the magnitude of therapeutic effects across these related psychosocial areas are scanty.…”

Pathophysiology and Treatment Options in Obstructive Sleep Apnoea: A Review of the Literature

“…Randomized control trials comparing oral appliances to CPAP are all crossover studies conducted in patients with symptomatic OSA. For polysomnographic outcomes, the mean values for AHI, oxygen saturation and sleep fragmentation favour CPAP in these studies [78,79]. For surgical interventions, the number and qualities of randomized control trails are poor and case series on UPPP suggest at best 50% improvement in 50% of the cases and is not recommended as a first line treatment [80,81].…”

Obstructive Sleep Apnea Oral Appliance vs. Auto Titrating Positive Airway Pressure

“…(Hoekema, 2004) (Hoekema, 2008) (Hoekema, 2009) (Pancer, 1999 (Levandowski, 2007) However, only nine studies have directly compared PAP to OA, and all of these studies used CPAP. (Ferguson, 1996) (Ferguson, 1997) (Engleman, 2002) (Tan, 2002) (Barnes, 2004) (Hoekema, 2008) (Lam, 2007) (Randerath, 2002) (Clark, Glenn, 1996) Seven of the studies used a cross--over design and 2 studies used parallel designs. In all 9 studies, patient questionnaires or diaries were used to document compliance with the OA while compliance for CPAP was derived from electronic data that CPAP machines, by design, inherently record.…”