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Better than sham? A double-blind placebo-controlled neurofeedback study in primary insomnia

View Article: PubMed Central - PubMed

ABSTRACT

See Thibault et al. (doi:10.1093/awx033) for a scientific commentary on this article.

Neurofeedback has been claimed to have therapeutic efficacy in multiple disorders. In a double-blind, placebo-controlled trial in insomnia, Schabus et al. report that sensorimotor rhythm neurofeedback (12–15 Hz) neither changes the EEG nor objectively improves sleep. While patients do report subjective improvements, these do not differ from those seen with placebo feedback.

No MeSH data available.


Related in: MedlinePlus

Study design. After participants had undergone an eligibility assessment (via email and phone) they came to the laboratory for a screening night to exclude sleep disorders besides insomnia. Then subjects completed four visits each, each one comprising two experimental nights with polysomnography (either preceded by a declarative or procedural learning task). In between Visits 1 and 2, and 3 and 4 all patients (patients with insomnia, misperception insomniacs) completed 12 sessions of NFT and PFT. Between Visits 2 and 3, a 3-month washout period was introduced and a final follow-up after 3 months was conducted. The order of NFT and PFT was counterbalanced (half of the patients receiving NFT first, and half of the patients receiving PFT first) and the protocol was kept double-blind until study completion.
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awx011-F1: Study design. After participants had undergone an eligibility assessment (via email and phone) they came to the laboratory for a screening night to exclude sleep disorders besides insomnia. Then subjects completed four visits each, each one comprising two experimental nights with polysomnography (either preceded by a declarative or procedural learning task). In between Visits 1 and 2, and 3 and 4 all patients (patients with insomnia, misperception insomniacs) completed 12 sessions of NFT and PFT. Between Visits 2 and 3, a 3-month washout period was introduced and a final follow-up after 3 months was conducted. The order of NFT and PFT was counterbalanced (half of the patients receiving NFT first, and half of the patients receiving PFT first) and the protocol was kept double-blind until study completion.

Mentions: Besides these two groups, we also included 31 age- and sex-matched healthy sleep controls (mean age = 35.52, SD = 10.63, 19 females) in the study. Importantly, this group did not undergo NFT or PFT, but only completed ‘Visit 1’ (Fig. 1) to obtain age- and sex-matched standard values for sleep and memory parameters. Insomnia patients were diagnosed according to the research criteria of Edinger et al. (2004) and had been free of medication for at least 2 weeks prior to study onset. Following an eligibility assessment [medical history, Pittsburgh Sleep Quality Index Questionnaire (PSQI), depression and anxiety questionnaires via email and phone] patients attended the lab where they were screened overnight more thoroughly for psychiatric disorders according to DSM-IV (American Psychiatric Association, 1995) using the Structured Clinical Interview for DSM disorders. They also completed additional questionnaires such as intelligence and personality questionnaires. Sleep controls did not have any history of past or current psychiatric disorders, which was verified through clinical interviews and the PSQI questionnaire (PSQI score ≤ 5; Buysse et al., 1989). Additionally, sleep controls could only take part in the study if their sleep efficiency during the screening night was < 1 SD below the average sleep efficiency in age- and sex-matched healthy sleepers (according to a European database: mean = 88.97; SD = 6.7; Anderer et al., 2005). Patients received a remuneration of €500 after study completion (€150 for block 1, and €350 for block 2) whereas the control group received €100. Recruitment was through announcements in local newspapers, radio, flyers at general practitioners’, and via our laboratory homepage.Figure 1


Better than sham? A double-blind placebo-controlled neurofeedback study in primary insomnia
Study design. After participants had undergone an eligibility assessment (via email and phone) they came to the laboratory for a screening night to exclude sleep disorders besides insomnia. Then subjects completed four visits each, each one comprising two experimental nights with polysomnography (either preceded by a declarative or procedural learning task). In between Visits 1 and 2, and 3 and 4 all patients (patients with insomnia, misperception insomniacs) completed 12 sessions of NFT and PFT. Between Visits 2 and 3, a 3-month washout period was introduced and a final follow-up after 3 months was conducted. The order of NFT and PFT was counterbalanced (half of the patients receiving NFT first, and half of the patients receiving PFT first) and the protocol was kept double-blind until study completion.
© Copyright Policy - cc-by-nc
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5382955&req=5

awx011-F1: Study design. After participants had undergone an eligibility assessment (via email and phone) they came to the laboratory for a screening night to exclude sleep disorders besides insomnia. Then subjects completed four visits each, each one comprising two experimental nights with polysomnography (either preceded by a declarative or procedural learning task). In between Visits 1 and 2, and 3 and 4 all patients (patients with insomnia, misperception insomniacs) completed 12 sessions of NFT and PFT. Between Visits 2 and 3, a 3-month washout period was introduced and a final follow-up after 3 months was conducted. The order of NFT and PFT was counterbalanced (half of the patients receiving NFT first, and half of the patients receiving PFT first) and the protocol was kept double-blind until study completion.
Mentions: Besides these two groups, we also included 31 age- and sex-matched healthy sleep controls (mean age = 35.52, SD = 10.63, 19 females) in the study. Importantly, this group did not undergo NFT or PFT, but only completed ‘Visit 1’ (Fig. 1) to obtain age- and sex-matched standard values for sleep and memory parameters. Insomnia patients were diagnosed according to the research criteria of Edinger et al. (2004) and had been free of medication for at least 2 weeks prior to study onset. Following an eligibility assessment [medical history, Pittsburgh Sleep Quality Index Questionnaire (PSQI), depression and anxiety questionnaires via email and phone] patients attended the lab where they were screened overnight more thoroughly for psychiatric disorders according to DSM-IV (American Psychiatric Association, 1995) using the Structured Clinical Interview for DSM disorders. They also completed additional questionnaires such as intelligence and personality questionnaires. Sleep controls did not have any history of past or current psychiatric disorders, which was verified through clinical interviews and the PSQI questionnaire (PSQI score ≤ 5; Buysse et al., 1989). Additionally, sleep controls could only take part in the study if their sleep efficiency during the screening night was < 1 SD below the average sleep efficiency in age- and sex-matched healthy sleepers (according to a European database: mean = 88.97; SD = 6.7; Anderer et al., 2005). Patients received a remuneration of €500 after study completion (€150 for block 1, and €350 for block 2) whereas the control group received €100. Recruitment was through announcements in local newspapers, radio, flyers at general practitioners’, and via our laboratory homepage.Figure 1

View Article: PubMed Central - PubMed

ABSTRACT

See Thibault et al. (doi:10.1093/awx033) for a scientific commentary on this article.

Neurofeedback has been claimed to have therapeutic efficacy in multiple disorders. In a double-blind, placebo-controlled trial in insomnia, Schabus et al. report that sensorimotor rhythm neurofeedback (12&ndash;15 Hz) neither changes the EEG nor objectively improves sleep. While patients do report subjective improvements, these do not differ from those seen with placebo feedback.

No MeSH data available.


Related in: MedlinePlus