A Sleep Position Trainer for positional sleep apnea: a randomized, controlled trial

TY - JOUR

T1 - A Sleep Position Trainer for positional sleep apnea

T2 - a randomized, controlled trial

AU - Laub, Rasmus R

AU - Tønnesen, Philip

AU - Jennum, Poul J

N1 - © 2017 European Sleep Research Society.

PY - 2017/10

Y1 - 2017/10

N2 - We tested the effect of the Sleep Position Trainer, a vibrational device, for positional sleep apnea in an open, randomized controlled trial with 101 patients, where 52 patients were allocated to Sleep Position Trainer and 49 patients to a non-treatment control group for 2 months (Part 1). All patients were then followed as a cohort for a period of 6 months with use of the Sleep Position Trainer (Part 2). The participants were assessed with polygraphy at entry, and after 2 and 6 months. The mean apnea-hypopnea index supine was 35 per h (SD, 18) in the Sleep Position Trainer group and 38 per h (SD, 15) in the control group at entry. In a per protocol analysis, the mean total apnea-hypopnea index at entry and after 2 months in the Sleep Position Trainer group was 18 per h (SD, 10) and 10 per h (SD, 9; P < 0.001) versus 20 per h (SD, 9) and 18 per h (SD, 10; NS) in the control group. The mean supine sleep time decreased from 47% (SD, 22) to 17% (SD, 18; P < 0.001) in the Sleep Position Trainer group after 2 months. In the control group, the mean supine sleep time was 48% (SD, 20) at entry and 39% (SD, 21; NS) after 2 months. The positive effect of Sleep Position Trainer was maintained in all patients treated with Sleep Position Trainer after 6 months. Daytime sleepiness improved after 6 months. Compliance with the Sleep Position Trainer device during the first 2 months, defined as use of Sleep Position Trainer >4 h per night for all weekdays, was 75.5% (SD 21.2). The discontinuation rate was 28.8 and 49.4% after 2 and 6 months, respectively.

AB - We tested the effect of the Sleep Position Trainer, a vibrational device, for positional sleep apnea in an open, randomized controlled trial with 101 patients, where 52 patients were allocated to Sleep Position Trainer and 49 patients to a non-treatment control group for 2 months (Part 1). All patients were then followed as a cohort for a period of 6 months with use of the Sleep Position Trainer (Part 2). The participants were assessed with polygraphy at entry, and after 2 and 6 months. The mean apnea-hypopnea index supine was 35 per h (SD, 18) in the Sleep Position Trainer group and 38 per h (SD, 15) in the control group at entry. In a per protocol analysis, the mean total apnea-hypopnea index at entry and after 2 months in the Sleep Position Trainer group was 18 per h (SD, 10) and 10 per h (SD, 9; P < 0.001) versus 20 per h (SD, 9) and 18 per h (SD, 10; NS) in the control group. The mean supine sleep time decreased from 47% (SD, 22) to 17% (SD, 18; P < 0.001) in the Sleep Position Trainer group after 2 months. In the control group, the mean supine sleep time was 48% (SD, 20) at entry and 39% (SD, 21; NS) after 2 months. The positive effect of Sleep Position Trainer was maintained in all patients treated with Sleep Position Trainer after 6 months. Daytime sleepiness improved after 6 months. Compliance with the Sleep Position Trainer device during the first 2 months, defined as use of Sleep Position Trainer >4 h per night for all weekdays, was 75.5% (SD 21.2). The discontinuation rate was 28.8 and 49.4% after 2 and 6 months, respectively.

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Patient Compliance

KW - Polysomnography

KW - Sleep Apnea Syndromes/metabolism

KW - Sleep Stages

KW - Time Factors

KW - Treatment Outcome

KW - Vibration/therapeutic use

U2 - 10.1111/jsr.12530

DO - 10.1111/jsr.12530

M3 - Journal article

C2 - 28370716

SN - 0962-1105

VL - 26

SP - 641

EP - 650

JO - Journal of Sleep Research (Print)

JF - Journal of Sleep Research (Print)

IS - 5

ER -