Palatal implants for the treatment of snoring and obstructive sleep apnea/hypopnea syndrome.
OBJECTIVE
Randomized, double-blinded, placebo-controlled, clinical trial to determine the effectiveness of palatal implants for treatment of mild/moderate obstructive sleep apnea/hypopnea syndrome (OSAHS).


METHODS
Sixty-two non-obese adults with history of snoring, daytime sleepiness, and mild/moderate OSAHS, were randomized to receive palatal implants (n = 31) or placebo procedure (n = 31). Complete follow-up including quality of life (QOL, SF-36), snoring visual analog scale (VAS), and Epworth Sleepiness Scale (ESS) data were obtained in 62 patients. Seven patients refused follow-up polysomnography for a total of 55 patients (29 implant and 26 placebo).


RESULTS
The treatment group (change in score of -7.9 +/- 7.7) was significantly improved compared with the placebo group (change in score of 0.9 +/- 4.3) for apnea/hypopnea index (AHI) (P < 0.0001), QOL, SF-36 (P < 0.0001), snoring VAS (P < 0.0001), and ESS (P = 0.0002).


CONCLUSIONS
Palatal implants improve AHI, QOL, snoring intensity, and daytime sleepiness for selected patients with mild/moderate OSAHS.
Friedman
Michael
M
Department of Otolaryngology and Bronchoesophagology, Rush University Medical Center, Chicago, IL, USA. hednnek@aol.com <hednnek@aol.com>
Schalch
Paul
P
Lin
Hsin-Ching
HC
Kakodkar
Kedar A
KA
Joseph
Ninos J
NJ
Mazloom
Narges
N
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010160:Palate, Soft / Q000601:surgery*; D017060:Patient Satisfaction; D017286:Polysomnography; D011446:Prospective Studies; D019736:Prostheses and Implants; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000379:methods*; D011788:Quality of Life; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D012913:Snoring / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D011795:Surveys and Questionnaires; D013577:Syndrome; D016896:Treatment Outcome