Lullaby Lollipop : Researchers Test Device to Help Insomniacs Sleep
Unable to sleep at night, Fay Lange worked out during the day at the gym--hoping she would exhaust herself into sleeping. It didn’t work.
Lange, 38, tried sleep tapes and relaxation tapes, self-hypnosis and hypnosis. She sipped wine at night and sunned herself during the day--in hopes of changing her body clock. She saw psychiatrists and, though she hates milk, she drank warm milk in the evenings.
She tried sleeping pills but they made her feel hung over. It was as though sleep, this phantom, danced just beyond her grasp. Her insomnia drove her to tears and despair.
“I can think of some torment I’d rather have--like bamboo under the fingernails, or something that’s short and quick,” said the Scripps Ranch resident.
Lange was skeptical when she heard about a device called a “silver lollipop” that emitted low-level electromagnetic radiation and supposedly put insomniacs to sleep. But she was also desperate, and so she enrolled in a trial program at San Diego’s Scripps Clinic and Research Foundation. After two weeks of treatment, Lange was sleeping seven hours--uninterrupted--each night.
For troubled sleepers such as Lange, proponents say this therapy could hold the promise of a nonaddictive alternative to prescription sleeping pills. If studies continue to yield the same results that have been shown on a small scale, say Scripps researchers, doctors someday may prescribe the treatment for insomniacs to use before bedtime in their own homes.
But other sleep experts caution that while the preliminary results are encouraging, too little is known about how and why the mechanism works, as well as whether it is safe. The brain is delicate, they warn, and scientists do not know whether the electromagnetic waves are adversely affecting other areas of the brain.
“It’s conceivable that they’ve hit upon a frequency and intensity that can deal with the system that’s involved with sleep. The problem is it doesn’t appear to be specific,” said Dr. Andrew Monjan, chief of neurobiology at the National Institute on Aging.
“We don’t know what else it’s doing. If it’s disturbing or altering one system, what’s it doing to the other systems?” asked Monjan, who is also executive secretary of the congressionally mandated National Commission on Sleep Disorders.
Still others voiced cautious optimism that this device--which must be approved by the federal Food and Drug Administration before general use--and electromagnetic radiation might prove a fruitful alternative to drugs.
“It holds promise. I was impressed by the initial results but it’s sufficiently unorthodox that further research needs to be done,” said Dr. Richard Allen, co-director of the Johns Hopkins University Sleep Disorders Center. “Just because it is not a drug doesn’t mean it doesn’t have problems.”
Since 1987, researchers at Scripps have studied and tested the silver lollipop, or low energy emission therapy (LEET). The aluminum-coated mouthpiece, placed in the mouth for 20 minutes before bedtime, emits low-level doses of electromagnetic radiation and it makes some insomniacs very sleepy, researchers say.
Of 120 chronic insomniacs tested at Scripps, about 80% fell asleep sooner and slept longer than they had before, said Dr. Roza Hajdukovic, a Scripps researcher investigating the device. In a study of 60 of those subjects, those who received the device fell asleep 52 minutes earlier and slept two hours longer than those who did not.
The research was a “double-blind” study in which a placebo lollipop was used with 30 of the patients, and researchers did not know which patients received the placebo or the real thing.
Dr. Milton Erman, head of Scripps’ division of sleep disorders, believes that the device may be an alternative to sleeping pills because it seems to be effective and safe, as well as nonaddictive. Last Sunday, he and Hajdukovic presented their findings at the World Federation of Sleep Research Societies in Cannes, France.
Experts estimate that 35% of Americans suffer insomnia at some time in their lives. Half of those sufferers end up taking sleeping pills, Hajdukovic said.
Though currently testing only patients whose insomnia is caused by psychological problems, Hajdukovic envisions that within five years, doctors might prescribe the device for a variety of troubled sleepers.
The silver lollipop is a flat, rectangular device that patients put in their mouth. The mouthpiece is attached to a 12-volt battery--about the size of a car battery. The Swiss manufacturer, Symtonic SA, recently created a model that has its own attached battery, making it portable, but Scripps is using the older version in the trials.
The device produces low-energy radio waves that Erman and Hajdukovic believe may trigger the release of calcium in the brain as well as a neurotransmitter, though they do not yet know why these chemicals are triggered, Erman said.
Because the electromagnetic waves are so low, about one-twentieth the strength of those produced by a cellular telephone, Erman believes the device is safe. But other sleep experts say the question of safety has not been adequately answered.
“You don’t have a cellular phone attached to the roof of your mouth close to your brain,” said Dr. G. Nino-Murcia, former director of the Stanford University Sleep Disorders Center and director of the Sleep Medicine and Neuroscience Institute in Palo Alto. “I have always been fearful of putting electromagnetic devices near the brain.”
The therapy is being independently tested in Europe and Denver as well as San Diego. In the Scripps study, funded by Symtonic, insomniacs received 20-minute doses of LEET three times a week for a four-week period. Most reported feeling the effects of the therapy after about three sessions.
But unlike medications, the treatments do not overwhelm patients with drowsiness. Instead, most reported that they experienced feelings of “well being” and were able to sleep at bedtime, Hajdukovic said.
There are still many unanswered questions and the study is continuing, researchers say. While Scripps researchers tested subjects between the ages of 21 and 50, they do not know if there is one age group that would be particularly susceptible to treatment. They also do not know how long the effects last. When the insomniacs ceased treatment, most continued sleeping longer hours, Hajdukovic said.
“This device can be stopped and its positive effects are still there, which means this device does not have the potential for abuse or dependence,” Hajdukovic said.
