Study links restless legs syndrome to poor sleep quality, impaired function in pregnancy

Press release:

DARIEN, IL – July 14, 2017 – A new study of pregnant women shows that restless legs syndrome (RLS) is common and is strongly associated with poor sleep quality, excessive daytime sleepiness, and poor daytime function, which are frequent complaints during pregnancy.

Results show that 36 percent of women in their third trimester had RLS, and half of the women with RLS had moderate to severe symptoms. Compared with pregnant women without RLS, those with RLS were twice as likely to report poor sleep quality and poor daytime function, and they were also more likely to have excessive daytime sleepiness. Additionally, the study found a positive dose-response relationship between RLS severity and the sleep-wake disturbances.

“While we expected that RLS would be relatively common in pregnant women, we were surprised to observe just how many had a severe form,” said lead author Galit Levi Dunietz, PhD, a T32 post-doctoral research fellow at the University of Michigan Sleep Disorders Center in Ann Arbor. “These women experienced RLS symptoms at least four times per week.”

Study results are published in the July 15 issue of the Journal of Clinical Sleep Medicine.

The study involved 1,563 pregnant women with an average age of 30 years, each of whom was in her third trimester. RLS was diagnosed using the standardized criteria of self-reported symptoms and frequency. Demographic and pregnancy data were extracted from medical records, and sleep information was collected with questionnaires. The study found no evidence for any association between RLS and delivery outcomes.

According to the authors, health care providers often dismiss patient complaints of poor sleep and daytime sleepiness during pregnancy.

“These sleep-wake disturbances are considered common symptoms in pregnancy and are frequently attributed to physiological changes that occur in normal pregnancy, but our data suggest that RLS is an additional contributor to these symptoms,” said Dunietz.

The authors suggest that the identification and treatment of RLS in pregnancy – using non-pharmacological approaches – may alleviate the burden of these symptoms for many women.

Foot wrap offers alternative to medication for patients with restless legs syndrome

Press release:

Authors from Lake Erie Research Institute in Pennsylvania report an adjustable foot wrap caused to treat restless legs syndrome (RLS) is 1.4 times more effective than the standard pharmaceutical treatment. The pilot study published today in The Journal of the American Osteopathic Association.

The eight-week clinical trial involved 30 otherwise healthy adults with moderate to severe restless leg syndrome. Researchers studied Clinical Global Impression responses as well as the mean change in the International Restless Leg Syndrome Study Group Study Scale (IRLSSGS). A meta-analysis was then used to compare the RLS device with three historic studies of the medication ropinirole and a placebo.

Clinical Global Impression responses indicated significantly greater improvement with the RLS device (90 percent) compared with ropinirole (63 percent), the current standard dopamine therapy for RLS. Additionally, change in IRLSSGS score was significantly greater for the RLS device (17.22) compared to historic reports for ropinirole versus the placebo (12 versus 8.9 respectively). Patients using the RLS device also reported an 82 percent decrease in sleep loss.

The RLS device was designed to put adjustable targeted pressure on two muscles in the foot known to relax symptoms of RLS, the abductor hallucis and the flexor hallucis brevis. Researchers indicate that the pressure produced by the device may also stimulate a dopamine release, similar to massage therapy or acupressure.

“By putting pressure on specific muscles in the feet, we are able to create a response in the brain that relaxes the muscles activated during RLS,” said Phyllis Kuhn, MS, PhD, and the study’s lead researcher. “It’s a near perfect example of the body regulating itself without drugs, many of which have the potential for significant adverse side effects.”

Restless leg syndrome (RLS) is a neurologic disorder causing unpleasant sensations and an urge to move the legs when at rest. The sleep loss associated with RLS can cause extreme fatigue, anxiety and depression. According to the National Institute of Health, RLS may affect as many as 10 percent of the U.S. population, with more than nine million experiencing moderate to severe symptoms.

Until recently, potent drugs including opioids, depressants and dopamine agonists have been used to ease symptoms, but each of these is accompanied by negative side effects such as dizziness, nausea, vomiting and the added risk of addiction.

“Restless legs syndrome really erodes quality of life because it causes extreme fatigue for many patients. As an osteopathic physician, it’s a challenge to balance the need to restore sleep while preventing additional harm from medication. These results show promise in otherwise healthy individuals for a nonpharmaceutical option that appears to have rather minor, temporary adverse effects for some users,” said Rob Danoff, DO, an osteopathic family physician and program at Aria Health Care in Philadelphia.

Adverse effects were reported by seven patients in the study. The effects included pain (1), pins and needles sensation (2), irritability (3), spasm (1) and warm feet (1).