BACKGROUND
In elderly people, aging alters sleep patterns, resulting in a high prevalence of sleep disorders, particularly insomnia, affecting around 40% of those aged 60 years and above. Severe sleep disturbances may lead to depression and cognitive impairments in elderly people [1]. Effective treatment is important but requires careful diagnosis and appropriate approaches due to age-related changes in drug response and limited effectiveness of Cognitive Behavioral Therapy for Insomnia (CBT-I) compared to younger adults [1]. Thus, there’s an urgent need for safer and more effective non-pharmacological treatments for elderly insomnia.
The transdermal trigeminal electrical neuromodulation (TTEN, The Cefaly, Belgium) device delivers transcutaneous electrical nerve stimulation to the forehead and was originally approved by the Korean Ministry of Food and Drug Safety for the treatment of migraines. It modulates neurotransmitters related to arousal and the sympathetic nervous system, with sleepiness being a common side effect [2]. This mechanism is believed to decrease hyperexcitability, potentially offering a treatment for insomnia. But there aren’t any organized studies about TTEN for treating insomnia. Here in, we present two cases of elderly patients with insomnia who experienced subjective symptom improvement and enhanced sleep efficiency after TTEN use.
CASE
Case 1
On November 5, 2021, a 61-year-old woman presented to the Psychiatry department at St. Vincent’s Hospital in Suwon, South Korea with complaints of insomnia. She did not have any underlying disease or medications that could affect her insomnia. Her body mass index (BMI) was 21.1 kg/m2, which is normal. She scored 10 points on Korean version of the Pittsburgh Sleep Quality Index (PSQI-K) and 16 points on Korean version of the Insomnia Severity Index (ISI-K), indicating poor sleep quality and moderate to severe insomnia respectively. Additionally, she scored 12 points on Korean version of the Epworth Sleepiness Scale (ESS-K), suggesting daytime sleepiness. Polysomnography (PSG) revealed suboptimal sleep efficiency (79.4%) (Table 1). Furthermore, with an apnea-hypopnea index (AHI) of 4/h, the patient’s daytime sleepiness was not attributed to obstructive sleep apnea (OSA). Additionally, the patient was not taking any medications that could induce insomnia. She refused CBT-I for her insomnia, we decided to treat her with TTEN. The patient underwent 12 weeks of daily TTEN sessions, lasting 20 minutes before bedtime, with intensities ranging from 1 mA to 16 mA during 20 minutes [3].
After 12 weeks of TTEN treatment, the patient’s PSQI-K score improved from 10 points to 8 points, indicating better sleep quality, and her ISI-K score decreased from 16 points to 9 points, reflecting improvement in insomnia. However, ESS-K score slightly increased from 12 points to 13 points, suggesting persistent daytime sleepiness. PSG results showed increased total sleep time to 452.5 minutes and improved sleep efficiency from 79.4% to 94.5%, with no change in sleep structure (Table 1).
Case 2
A 72-year-old woman presented to the Psychiatric department at St. Vincent Hospital in December 2021 with sleep disturbances. She also didn’t have any underlying diseases or medications that could affect her symptoms. Her BMI also was normal at 21.8 kg/m2. Her PSQI-K score was 6 points, which was lower than that of case 1 patient, while her ISI-K score was 11 points, indicating mild insomnia. However, her ESS-K score was 3 points, indicating no daytime sleepiness. PSG showed good sleep efficiency (96.6%). She had mild OSA (AHI: 9.7/h), did not report daytime sleepiness, and was not taking any medications that could induce insomnia. She also didn’t want to do CBT-I, so like case 1, she underwent 12 weeks of daily TTEN sessions before bedtime with the same intensity. After treatment, her PSQI-K score improved from 6 to 5 points, and her ISI-K score decreased from 11 to 3 points, indicating better sleep quality and fewer insomnia symptoms. ESS-K score remained unchanged at 3 points (Table 1).
DISCUSSION
In this case series, two patients reported subjective improvement in insomnia symptoms after 12 weeks of TTEN application. This improvement was more significant in those with severe insomnia symptoms and decreased sleep efficiency on PSG before treatment. Patients with moderate to severe insomnia experienced a reduction in symptoms below baseline, accompanied by notable improvements in PSG-measured sleep efficiency. Studies have also shown TTEN’s potential to improve insomnia.
The hyperarousal model proposes that insomnia stems from neurophysiological changes triggered by predisposing and precipitating factors like psychological stress and prolonged bed rest. These changes include autonomic hyperactivity and dysregulation of the noradrenergic system [4]. TTEN is believed to modulate the locus coeruleus, reducing autonomic activity and inducing a sedative effect [2]. Patients in the case series experienced subjective improvement in insomnia symptoms, with one also showing improved sleep efficiency on PSG. Despite normal PSG results, the other patient reported subjective improvement, possibly due to sleep state misperception, which can be influenced by increased physiological arousal [5]. TTEN may have mitigated hyperarousal in both cases, leading to subjective improvement in insomnia.
In this case series, one patient showed both subjective and objective improvements in insomnia symptoms with TTEN, while another patient only showed subjective improvement. No serious adverse effects were observed, suggesting TTEN’s potential as a safe non-pharmacological treatment for elderly insomnia. However, larger, well-designed studies are necessary for conclusive evidence.
The Institutional Review Board of the Catholic University of Korea (VC24ZISI0088) determined that this study was exempt from informed consent requirements, as all patient data were fully anonymized and retrospective in nature. Furthermore, this case series report was conducted in accordance with the principles of the Declaration of Helsinki.
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