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Placebo and modafinil effect on sleepiness in obstructive sleep apnea.
Prog Neuropsychopharmacol Biol Psychiatry. 2008 Feb 15; 32(2):552-9.PN

Abstract

INTRODUCTION

Previous studies have evaluated the effect of modafinil on residual excessive daytime sleepiness (EDS) in patients with obstructive sleep apnea syndrome (OSAS) under effective CPAP treatment. Even though those trials also used placebo groups, we suppose that the placebo effect might influence the patients' response to modafinil.

METHODS

Twenty sleepy patients with OSAS under CPAP treatment were selected. All of them had Epworth Sleepiness Scale (ESS) >10. Following baseline evaluation (T1), all subjects were instructed to take placebo for 7 days. After this single-blind placebo phase and second evaluation (T2), patients were randomly allocated to placebo or modafinil treatment for 21 days in a double-blind protocol. Patients underwent a final evaluation (T3) on the last day of drug intake. The evaluations at T1, T2 and T3 consisted of: medical and laboratory examinations, nocturnal polysomnography, ESS, maintenance of wakefulness test (MWT) and complex reaction time (CRT-NY). In addition, in T2 and T3 the change of illness severity scale (CGI-C) and the evaluation of quality of life (SF-36) were applied.

RESULTS

The comparison between the two groups during the three periods studied, showed the following results: in the modafinil group, ESS score did not change during the initial placebo period, but there was a significant reduction during the modafinil treatment period (p=0.0006); in the placebo group a significant reduction occurred during the initial placebo period (p=0.05), and no further change was observed in the treatment (placebo) period. A significant difference was found between the two groups after the placebo period (T2) (p=0.02). Three patients (33%) of the modafinil group and 9 patients (81%) of the placebo group were classified as placebo-responsive (X2: p=0.039). In the treatment period, reaction time was significantly reduced in the modafinil group compared to the placebo group (p<0.02). There was a trend toward improvement in overall clinical condition and also in some domains of SF-36 in the modafinil group.

CONCLUSION

In summary, our study confirms that modafinil used adjunctively with CPAP therapy improves subjective daytime sleepiness in patients with OSAS who were regular users of CPAP therapy but still experienced sleepiness. Moreover, it could help in the improvement of objective measures of behavioral alertness and reduce functional impairments. The usefulness of a blinded placebo period for systematic investigation of placebo role in studies based on subjective response is a point that should be considered in this type of drug trial.

Authors+Show Affiliations

Sleep Medicine and Biology Discipline, Psychobiology Department, Universidade Federal de São Paulo, Napoleão de Barros 925, São Paulo 04024-002, SP Brazil. lia@psicobio.epm.brNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18053628

Citation

Bittencourt, Lia Rita A., et al. "Placebo and Modafinil Effect On Sleepiness in Obstructive Sleep Apnea." Progress in Neuro-psychopharmacology & Biological Psychiatry, vol. 32, no. 2, 2008, pp. 552-9.
Bittencourt LR, Lucchesi LM, Rueda AD, et al. Placebo and modafinil effect on sleepiness in obstructive sleep apnea. Prog Neuropsychopharmacol Biol Psychiatry. 2008;32(2):552-9.
Bittencourt, L. R., Lucchesi, L. M., Rueda, A. D., Garbuio, S. A., Palombini, L. O., Guilleminault, C., & Tufik, S. (2008). Placebo and modafinil effect on sleepiness in obstructive sleep apnea. Progress in Neuro-psychopharmacology & Biological Psychiatry, 32(2), 552-9.
Bittencourt LR, et al. Placebo and Modafinil Effect On Sleepiness in Obstructive Sleep Apnea. Prog Neuropsychopharmacol Biol Psychiatry. 2008 Feb 15;32(2):552-9. PubMed PMID: 18053628.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Placebo and modafinil effect on sleepiness in obstructive sleep apnea. AU - Bittencourt,Lia Rita A, AU - Lucchesi,Ligia M, AU - Rueda,Adriana D, AU - Garbuio,Silvério A, AU - Palombini,Luciana O, AU - Guilleminault,Christian, AU - Tufik,Sergio, Y1 - 2007/10/30/ PY - 2007/08/02/received PY - 2007/10/19/revised PY - 2007/10/20/accepted PY - 2007/12/7/pubmed PY - 2008/5/31/medline PY - 2007/12/7/entrez SP - 552 EP - 9 JF - Progress in neuro-psychopharmacology & biological psychiatry JO - Prog Neuropsychopharmacol Biol Psychiatry VL - 32 IS - 2 N2 - INTRODUCTION: Previous studies have evaluated the effect of modafinil on residual excessive daytime sleepiness (EDS) in patients with obstructive sleep apnea syndrome (OSAS) under effective CPAP treatment. Even though those trials also used placebo groups, we suppose that the placebo effect might influence the patients' response to modafinil. METHODS: Twenty sleepy patients with OSAS under CPAP treatment were selected. All of them had Epworth Sleepiness Scale (ESS) >10. Following baseline evaluation (T1), all subjects were instructed to take placebo for 7 days. After this single-blind placebo phase and second evaluation (T2), patients were randomly allocated to placebo or modafinil treatment for 21 days in a double-blind protocol. Patients underwent a final evaluation (T3) on the last day of drug intake. The evaluations at T1, T2 and T3 consisted of: medical and laboratory examinations, nocturnal polysomnography, ESS, maintenance of wakefulness test (MWT) and complex reaction time (CRT-NY). In addition, in T2 and T3 the change of illness severity scale (CGI-C) and the evaluation of quality of life (SF-36) were applied. RESULTS: The comparison between the two groups during the three periods studied, showed the following results: in the modafinil group, ESS score did not change during the initial placebo period, but there was a significant reduction during the modafinil treatment period (p=0.0006); in the placebo group a significant reduction occurred during the initial placebo period (p=0.05), and no further change was observed in the treatment (placebo) period. A significant difference was found between the two groups after the placebo period (T2) (p=0.02). Three patients (33%) of the modafinil group and 9 patients (81%) of the placebo group were classified as placebo-responsive (X2: p=0.039). In the treatment period, reaction time was significantly reduced in the modafinil group compared to the placebo group (p<0.02). There was a trend toward improvement in overall clinical condition and also in some domains of SF-36 in the modafinil group. CONCLUSION: In summary, our study confirms that modafinil used adjunctively with CPAP therapy improves subjective daytime sleepiness in patients with OSAS who were regular users of CPAP therapy but still experienced sleepiness. Moreover, it could help in the improvement of objective measures of behavioral alertness and reduce functional impairments. The usefulness of a blinded placebo period for systematic investigation of placebo role in studies based on subjective response is a point that should be considered in this type of drug trial. SN - 0278-5846 UR - https://www.unboundmedicine.com/medline/citation/18053628/Placebo_and_modafinil_effect_on_sleepiness_in_obstructive_sleep_apnea_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0278-5846(07)00385-5 DB - PRIME DP - Unbound Medicine ER -