Device Proves a Real Sleeper : Science: Scripps researchers test an electromagnetic ‘Silver Lollipop’ that helps some insomniacs to 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.

At the height of her insomnia, she didn’t sleep at all some nights; other nights, she slept no more than two hours. She found herself yelling at her 11-year-old daughter for dawdling in front of the mirror before school. She’d go into her office, pop open a Pepsi at 8:30 a.m.--sucking up the caffeine so she could face a growing stack of papers at her desk.

“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 like Lange, 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 may someday 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’s safe. The brain is delicate, they warn, and scientists still don’t 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 which 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?” said 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 in Baltimore. “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. The aluminum-coated mouthpiece, placed in the mouth for 20 minutes before bedtime, emits low-level doses of electromagnetic radiation making some insomniacs very sleepy, researchers say.

Of 120 chronic insomniacs tested at Scripps, about 80% fell asleep sooner and slept longer, said Dr. Roza Hajdukovic, a Scripps researcher investigating the device. In a double blind study of 60, those who received the device fell asleep 52 minutes earlier and slept two hours longer than did their counterparts.

Dr. Milton Erman, head of Scripps’ Division of Sleep Disorders, admits that he was somewhat embarrassed by the Silver Lollipop trials. Initially, when he talked with his colleagues, the device was the butt of many jokes and much skepticism.

“You talk about something like this and it takes on a certain air--there have been a lot of wacky devices that people associate with non-scientific approaches,” Erman said.

But once researchers ironed out glitches and got the Silver Lollipop functioning properly, the results were startling and statistically significant, Erman said.

In fact, Erman now believes the device may be a worthy alternative to sleeping pills since it seems to be effective and safe, as well as nonaddictive. And on Sunday2, 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. And half of those sufferers end up taking sleeping pills, Hajdukovic said.

Doctors now agree that insomnia is just a symptom that can be caused by a variety of medical problems, ranging from Parkinson’s and Alzheimer’s diseases to arthritis and post-surgical discomfort. And it can also be caused by mental conditions, such as depression and stress.

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 to have in their homes.

“I believe this will be used not only for people with (psychologically induced) insomnia but I feel this device may have use in other insomnias,” Hajdukovic said.

The Silver Lollipop is a rectangular, flat device that the patient puts in the mouth like a candy sucker. 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 completely 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 and a neurotransmitter in the brain. It is not yet understood how--and why--these chemicals are released, 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, Denver and at Scripps. In the Scripps study, funded by Symtonic, insomniacs received 20-minute doses of the Silver Lollipop 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.

Scripps researchers tracked how long it took patients to fall asleep, how long they slept, and whether their sleep was uninterrupted. Those getting the treatment fell asleep 20% faster than the control group.

“If you give a person two hours more sleep each night, that’s a lot,” Hajdukovic said. “They’ll be singing.”

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 don’t know, for instance, if there’s one age group that would be particularly susceptible to treatment. And they also don’t know how long the affects 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.

Karen Yasgoor, a La Jolla management consultant, began her treatment in 1987 after suffering a post-surgery insomnia that went on for months and months. The treatment has taken hold and still works, she says.

“I’m pretty much OK, I don’t think I’ll ever be a great sleeper,” Yasgoor said. “Five or six hours is all I can expect but that’s great for me.”

Hajdukovic and Erman hope the Silver Lollipop will allow doctors to avoid prescribing the traditional solution to insomnia: Sleeping pills. Benzodiazepines, a family of sleep-inducing drugs that includes Halcion and Dalmane, have become a $200-million-a-year market in the United States.

But increasing numbers of patients are finding that such medications can have devastating consequences.

Jean Deangelis, 41, a San Diego home health aide for the elderly, began taking a benzodiazepine drug almost a decade ago when a doctor prescribed it to combat her heart palpitations, she said. In fact, Deangelis didn’t realize the pills she took were for sleeping, she said.

In March 1989, Deangelis decided she was going to turn 40 in style. Three months before her birthday, she began exercising and dieting. As she trimmed down and firmed up, she also decided she’d cut out her medication she’d taken for eight years.

But when she tried to stop, she ceased sleeping. After five sleepless nights, Deangelis became hysterical. Was this going to last the rest of her life, she wondered. Those five nights were a small taste of the next year and a half, as Deangelis painfully weaned herself off benzodiazepine drugs.

“I was totally incapacitated. I couldn’t drive--the pain in my head was so unbearable. I felt like my eyes were on fire. I shook,” Deangelis said. “My life had ended. I stayed on the sofa or in bed. I just lost my capacity to sleep. My whole day evolved around waiting for night to come--hoping I would sleep.”

Though Deangelis had heard of the Silver Lollipop, she could not enter Scripps’ study until she was off benzodiazepine drugs. Deangelis pinned all her hopes on the electromagnetic radiation treatment.

“I remember thinking that if this doesn’t work, people are going to read about me jumping off the Coronado Bridge,” Deangelis said.

When Deangelis entered the study program, Scripps researchers monitored her sleep on the first night. It took her 56 minutes to fall asleep.

In bed that night, she slept less than 90 minutes because she woke up so often. In all, she slept 27% of the time she was in bed. In contrast, a normal person sleeps 85% of the time he spends in bed, Hajdukovic said.

Deangelis said she felt a difference from her very first treatment. As she lay on the bed in the research room, perspiration was dripping off her hands and her heart was racing. But slowly, she felt the sweat dry and her heart slow. After 15 minutes, the tension eased out of her neck.

She went home and slept for four hours after the first treatment. Soon she was sleeping seven hours, she said.

After Deangelis’ treatment ended in August, researchers again monitored Deangelis’ sleep. This time, she fell asleep in 12 minutes and slept seven hours, or 88% of the time she spent in bed.

“I hadn’t woken up refreshed in so long that I’d forgotten what it was like,” Deangelis said. “If you could see me wake up--I am the happiest girl on the block. I’m in a great mood, I’m rested. I don’t have pounding in my head, ringing in my ears. I don’t need a cup of coffee.”