Elon Musk’s brain chip company Neuralink said on Thursday that it now has regulatory approval in the US to test its implants in human subjects. Neuralink has been building chips to be implanted into the skull for a brain-computer interface, claiming their development has the potential to help restore vision in the blind, and even help paralysed people walk again. While Mr Musk has said on several occasions since 2019 that the company is ready to go for experiments in humans to treat paralysis and blindness, the US Food and Drug Administration (FDA) had however rejected proposals by the company to begin human clinical trials. For instance, in early 2022, when Neuralink applied for human testing, the FDA rejected the proposal saying there were “dozens of issues the company must address”. These issues flagged by the FDA included the use of lithium batteries in Neuralink’s device and the likelihood of the implant’s wires interfering with the brain. The federal agency also expressed concerns about whether the firm’s implants can be removed without causing brain damage. Neuralink has also come under the scanner of at least one US government probe after animal rights watchdogs accused the firm of “inadequate care” of its research monkeys. Reuters previously reported that the brain chip company killed about 1,500 animals, including over 280 sheep, pigs and monkeys since 2018. The US Department of Agriculture also began investigating Neuralink’s potential violations of the Animal Welfare Act. Responding to the animal abuse complaints, the company said in a blogpost that it was “absolutely committed to working with animals in the most humane and ethical way possible”. “The use of every animal was extensively planned and considered to balance scientific discovery with the ethical use of animals,” it said. In a tweet in November last year, Mr Musk said he was confident that Neuralink’s device was “ready for humans”, adding that the timing for beginning human trials was a “function of working through the FDA approval process”. “We want to be extremely careful and certain that it will work well before putting a device into a human but we’ve submitted I think most of our paperwork to the FDA and probably in about six months we should be able to upload Neuralink in a human,” the Tesla and SpaceX chief said. On Thursday, the company said it has finally received approval from the federal agency to begin trials in humans. “We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!” the brain chip company said. The FDA approval “represents an important first step that will one day allow our technology to help many people”, Neuralink said, adding that it would soon announce more information on the recruitment of people for clinical trials. FDA hasn’t immediately responded to The Independent‘s queries on the Neuralink approval claim. Read More What is superintelligence? How AI could replace humans as the dominant lifeform on Earth Elon Musk’s Neuralink probed over shipment of ‘contaminated’ devices from ‘infected’ monkey brains When sci-fi becomes reality: could brain-machine interfaces be right around the corner?

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Ever find yourself awake, staring into space at four in the morning? Is it just a bad habit, or is there something more sinister going on? And why does it always seem to happen at 4am? “We start to experience less deep sleep after around four to five hours,” says Lisa Artis, deputy CEO of The Sleep Charity, who have partnered with Simba mattresses. And once we’re in that lighter sleep faze, we wake much more easily. If you generally fall asleep around 11pm – which is a very common bedtime, 4am wake-ups are more likely. And there are many factors leading to these inconvenient stirrings. Hormones “Sleep is guided by our internal clock or circadian rhythm. One of the most significant and well-known circadian rhythms is the sleep-wake cycle,” Artis continues. “Sleep is regulated by the levels of two hormones: melatonin and cortisol, which follow a regular 24-hour pattern. Melatonin assists you in dozing off, while cortisol helps get you up, and keeps you awake,” she explains. Keeping an eye on your hormones is important in preventing those late-night wake-ups. “Engage in calming activities before bedtime, such as reading, listening to soothing music, or practising relaxation techniques, like deep breathing or meditation,” says Dr Mariyam H. Malik, GP at Pall Mall Medical. Equally, pop your phone down for a bit. “Blue light from electronic devices can suppress melatonin production. Try to avoid screens for at least two hours before bedtime, or use blue light filters. It is best to charge them in a separate room overnight,” Malik adds. Diet Caffeine, heavy meals, alcohol, sugar, and a lack of magnesium or B vitamins could lead you to have a more disturbed night’s sleep, according to Malik. Sugar and carbohydrates may have a particular impact. “A diet high in sugar and refined carbohydrates can cause blood sugar fluctuations, leading to wakefulness during the night,” she says. “It’s unlikely you’ll feel hungry in the middle of the night if your blood sugar dips,” notes Artis, “but to reduce ungodly hour awakenings, trial alternatives for your last meal or snack of the evening. Instead of carb or sweet-based snacks, opt for protein-packed and magnesium-rich foods, like hard boiled eggs, cottage cheese, pumpkin seeds, spinach, dark chocolate, cashews, chicken thighs or turkey.” Protein can take the edge off your night-time hunger, she says, while magnesium is known to support sleep. Needing a wee Do you wake up needing to wee at the same time every night? “Try not to drink excessive amounts of fluids before bedtime,” advises Malik. “It’s important to stay hydrated, but try not to drink anything for around two hours before your usual bedtime. Go to the toilet before you go to bed to empty your bladder. ” Age and life stage “Sleep tends to become more disrupted as people get older,” Malik explains. “Sleep patterns change with age, and various factors can contribute to sleep disturbances in older adults. Some common reasons for sleep disruption in the elderly include changes in your circadian rhythm, decreased melatonin production, medical conditions or medications, and potential sleep disorders.” It can also affect women during the perimenopause. “The reproductive hormones – oestrogen and progesterone – are entwined with the sleep and relaxation hormones, melatonin and serotonin,” says Artis. “When oestrogen begins to fall before and during menopause, it can create a disturbance in the sleep-promoting hormone melatonin, meaning it can’t properly balance out cortisol. When this happens, the ability to fall and stay asleep is affected.” Recurring hot flushes, night sweats, dry skin, and low libido can signal waning oestrogen. Artis advises incorporating foods with high levels of phytoestrogens into your diet throughout the day to help with this. “Phytoestrogens imitate the natural estrogens found in your body. As a consequence, they can bind to your body’s oestrogen receptors and produce similar effects.” Try lentils, kidney beans, chickpeas, tofu, edamame, spinach, cauliflower and broccoli. Worrying Stress is not good for sleep. One study by Bupa even found that 32 million Brits wake up worrying about their health at precisely 4:05 am. The report, which surveyed 4,000 British adults, revealed that more than three-fifths of us wake up in the middle of the night. If you are finding yourself awake at all hours worrying, or waking up with stressful dreams, there are a few things that may help. “Keep a journal by your bedside and write down your worries before going to bed. This practice can help get your concerns out of your mind and onto paper, making it easier to let go of them temporarily,” says Malik. You may also want to “engage in mindfulness or meditation exercises before bedtime. Mindfulness can help you focus on the present moment, reducing anxiety about the past or the future.” Read More Men have a problem – and it won’t be solved by either Andrew Tate or Caitlin Moran Elon Musk reacts to ex-wife Talulah Riley’s engagement to Thomas Brodie-Sangster Thomas Brodie-Sangster references Love Actually in sweet engagement announcement with Talulah Riley Charity boss speaks out over ‘traumatic’ encounter with royal aide Ukraine war’s heaviest fight rages in east - follow live

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