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Therapeutic Effectiveness and Patient Acceptance of a Vestibular Nerve Activation Intervention in Chronic Insomnia.

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MEDI CAMU NDI 54/2 2010 89
Investigations and research
Therapeutic effectiveness and patient acceptance
of a vestibular nerve activation intervention
in chronic insomnia
Defined as: “Complaints of disturbed sleep in
the presence of adequate opportunity and
circumstance for sleep”, insomnia is one of the
most common presenting symptoms in the
primary care setting [1, 2]. The disturbance may
consist of one or more of three features:
• difficulty in initiating sleep
• difficulty in maintaining sleep
• waking up too early [3].
Insomnia can have a serious impact on work
performance and maintaining healthy social
relationships [4]. Chronic insomnia is
differentiated from acute insomnia by individuals
experiencing at least one of the symptoms
described above for a minimum of 30 days [3].
Predictably, there has been a wealth of research
in the areas of assessment and treatment for this
sleep disorder, given the impact insomnia has
been shown to have on mental and physical health
and wellbeing [3-5]. Incidence rates are routinely
around 9% of the general population, escalating
to 30% for those who report occasional suffering
[6]. Many individuals continue to report
symptoms of insomnia for many years after
initial onset [7]. Areas of particular interest to
clinicians, health-care professionals and insomnia
sufferers include implementation, acceptance
and adherence to therapies that provide effective
long-term management.
Conventional treatments include prescription
medications (sedative-hypnotics), cognitive-
behavioral therapy (CBT) and other alternative
therapies (e.g. alcohol, herbal remedies and
off-label use of other medicines) [3]. While
sedative-hypnotics and CBT have been shown
to be effective in the treatment of insomnia [3,8],
expert opinion counsels against long-term use
of sedative-hypnotics due to residual sedation,
rebound insomnia, memory impairment,
dependency and withdrawal difficulties [9, 10].
In addition, CBT is not easily accessed and
patients frequently have difficulty adhering to
the strict behavioral program that is typically
prescribed [11]. A further area of concern is the
limited evidence supporting the efficacy and
safety of alternative therapies, despite their
widespread use [3].
One promising approach to managing chronic
insomnia is non-invasive mechanical vestibular
nerve stimulation, which has been demonstrated
to affect sleep [12-17]. The vestibular apparatus,
in conjunction with visual and proprioceptive
inputs, is responsible for maintaining balance
under all conditions. Previous studies have used
a mechanical rocking motion to induce vestibular
activation, mimicking the sensation of infants
being comforted by their parents. Improvements
in sleep architecture and increased Total Sleep
Time, Sleep Efficiency, Rapid Eye Movement
and decreased Sleep Onset Latency have been
demonstrated when using this technique [12-17].
A unique therapy, designed to non-invasively
stimulate the vestibular nerve to promote sleep
onset, has recently been developed. As an
alternative to the rocking motion delivered by
mechanical action, a swaying sensation is
artificially created through mild electrical
stimulation. Clinical studies have been previously
conducted to investigate both the safety and
efficacy of this medical device for the treatment
of insomnia via a transient insomnia model,
with positive outcomes [18, 19].
Individuals with chronic insomnia report similar
issues in sleep disturbance to those in transient
insomnia, but persistent in nature. Given the
limitations of current effective therapies, and the
recent emphasis on patient-centered care [20],
there is an increasing need for an alternative
treatment for insomnia symptoms. It has been
shown that patient preference for non-
pharmacological treatment was over three times
greater than prescription medications [21].
Thus many would prefer a non-pharmaceutical
approach if an effective one were available [11].
Vestibular nerve activation may provide such a
treatment for chronic insomnia.
M.J.Marshall
J.G. Jasko
H. Zhang
UNSW Research Centre for Primary Health Care and Equity
University of New South Wales, NSW 2052,
Australia.
Insomnia can have
a serious impact on
work performance
and maintaining social
relationships.
E
A unique therapy has
been developed to
non-invasively stimulate
the vestibular nerve to
promote sleep onset.
E
90 MEDI CAMU NDI 54/2 2010
• time of sleep onset
number of awakenings during night and the
reason for this
• final time of awakening
• total sleep time and total time in bed.
Also explored were participants’ opinions of their
waking state and energy levels for the previous
day. These journals were to be completed on
awakening to minimize recollection errors.
Orientation and training on the SleepWave were
managed in two ways: at a central site, or
remotely. All participants were encouraged to
attend central sites, located in Pittsburgh,
Chicago, Dallas, New York, and San Francisco.
Completed baseline sleep journals were recovered
where available. Participants completed a
baseline questionnaire including demographic
data, current sleep habits and the Insomnia
Severity Index (ISI) [22]. The ISI is a seven-item
questionnaire assessing the nature, severity, and
impact of sleep difficulties for the preceding
month. A Likert scale is used to rate each item,
with a possible score between 0–28. Scores can
be classified into 4 categories: absence of
insomnia (0-7); sub-threshold insomnia (8-14);
moderate insomnia (15-21) and severe insomnia
(22-28). In addition to determining the baseline
severity, the ISI is sensitive enough to measure
treatment outcome [23].
Comprehensive training on operating the
SleepWave was given. For those participants who
did not attend one of the central sessions, a DVD
training guide was provided and telephone
support was offered in addition to the training
materials.
Sleep journals were completed daily for the
duration of the study. In addition, telephone
interviews exploring experiences using the medical
device were conducted on day 7 and day 14 of
the study. An on-line questionnaire was provided
as an alternative for participants who were
unable to complete the interviews by telephone.
A final interview was held for all participants on
completion of the 30-day study. These were held
at the five central sites for the majority of
participants. The final interview consisted of a
questionnaire incorporating questions recorded
in previous interviews which examined their sleep
habits, frequency of device usage, and use of
alternative interventions (medications or other)
taken during the study. A post intervention ISI
was also completed.
Design and methods
Objectives
An open-label trial, without control, of 30 days’
non-invasive vestibular nerve stimulation in adults
with self-reported chronic insomnia was
conducted in order to examine the acceptance
and effectiveness of a novel medical device as a
treatment for managing chronic insomnia
symptoms.
Participants
Participants between 21 to 65 years of age who
reported a history of chronic insomnia were
recruited to the study. Excluded from the study
were persons:
taking medications, including over-the-counter
or herbal medicines, which affected sleep/wake
function (unless the medication was used to
promote sleep)
• with unstable or untreated psychiatric illness
with a diagnosis of, or highly likely to have, a
sleep disorder that was unstable or untreated
with pre-existing medical conditions contra-
indicated for vestibular nerve stimulation
• with any disorder initiating seizures
with an electronic implanted device or
hearing aid
• who were pregnant
who were currently under going electrical
monitoring
with a history of falls, or who had previously
participated in a vestibular nerve stimulation
study.
All participants enrolled into the study provided
informed, written consent.
The protocol was approved by the appropriate
Institutional Review Board at each investigative
site.
Intervention
Non-invasive electrical vestibular nerve
stimulation was applied via the Philips SleepWave
device (Figure 1). Stimulation was initiated by
participants, as required, to expedite sleep onset.
The stimulating electrode is shielded in an ear
spiral fitted behind the ear. Once activated, each
stimulation had a one-hour duration. The device
was programmed to deliver a peak current from
0.1–1.0 mA at a frequency of 0.5 Hz.
Assessment and measures
Eligible participants were asked to complete a
baseline sleep journal for one week prior to an
orientation and training session, in order to
determine baseline measurements before the
commencement of the study. The sleep journal
included self-reports pertaining to:
An open-label trial was
conducted of 30 days’ non-
invasive vestibular nerve
stimulation in adults.
E
Non-invasive electrical
vestibular nerve
stimulation was applied
via the Philips SleepWave
device.
E
MEDI CAMU NDI 54/2 2010 91
time, wake after sleep onset and sleep efficiency
was shown between baseline and 30 days (Table 1).
As baseline data limited the analysis of this study
population, comparisons between subjects with
and without baseline data was explored for
recorded sleep onset latency measures to try to
determine whether the reported improvement
was comparable between groups. A mixed model
was performed including those subjects with and
without baseline data, and the repeated measures
factor of time (weeks 1-4). No significant
difference was observed between those with
baseline data and those without (p=.983).
Furthermore, there was no significant interaction
between subject group and time (p=.933),
suggesting that the change in sleep onset latency
Adverse events
A 24/7 toll-free helpline number was provided
to all participants for technical, medical or
general issues during the study period.
Previously reported adverse events using the
SleepWave included headaches, nausea, dizziness,
and skin irritation causing tingling, warmth or
itching. No serious adverse events had been
reported in previous studies [14, 15].
Results
Baseline data
In total, 105 participants were enrolled into the
study. Five participants (all female) withdrew
from the study within the first week of data
collection. Of these, three reported an inability
to tolerate treatment and two withdrew without
giving a reason. Mean age at entry (n = 86) was
43.8 years (SD ± 10). Gender data were
available for 91 participants (59/91 female),
resulting in a 2:1 female:male ratio.
The majority (75/105) attended a face-to-face
centrally conducted orientation and training
session held at one of the five US city sites, with
the remaining participants being instructed via
telephone and a DVD training aid.
Seven-day baseline sleep journal data and ISI
scores was collected from 43/105 and 89/105
respectively, confining our pre/post analysis to
41% and 85% of our sample population.
SleepWave intervention usage
Sleep journal data were available for 100
individuals. These data showed that the device
was initiated once per night during 61% of the
nights; twice per night during 11% of the nights;
3 or more times 4% of nights and not used at all
during 24% of the total nights (n = 2525).
Outcomes
The primary outcome was evidenced by means
of the ISI data sets at baseline and at 30 days
post intervention (n = 89). Comparison of pre
and post ISI scores using Wilcoxon Signed Ranks
test (nonparametric) showed a statistically
significant improvement in this study population
(Mean(SD) 17.8(4.0) and 11.8(5.4) p<.001).
Additionally, the insomnia severity distributions
differed significantly between baseline and
30 days post intervention (Figure 2, McNemar
Test, p< .001), showing a significant improvement
in the group ISI scores pre-and post-intervention.
Secondary outcome measures of participant
recorded and investigator calculated sleep
variables demonstrated statistically significant
improvement in sleep onset latency, total sleep
G
Figure 1. Philips SleepWave.
F
Figure 2. Distribution of Insomnia
Severit y Index (ISI) class by study
interval
1
2
92 MEDI CAMU NDI 54/2 2010
It is important to note that this study employed
a purely “as required” therapy regimen. Giving
individuals complete autonomy to determine
whether or not to activate the SleepWave resulted
in variable use of the medical device by
participants in this study. While it is common
for prescription medication management to be
of a fixed nightly dose, participants did not
necessarily feel the need to use the device every
night. This is possibly due to the waxing and
waning nature of insomnia symptoms and
appears to be beneficial compared to that of fixed
dosing as it empowers individuals in managing
their symptoms. This autonomy potentially
provides a more realistic approach to insomnia
management [24].
Although this study was open-label and without
a control it has been suggested that: “optimal
trial conditions (efficacy) misrepresents the real
world (effectiveness) where variations in clinical
skills, the intensity and duration of interventions,
patient adherence, and local resources influence
outcomes” [25]. Considering this, and the
limitations in current treatments, a non-invasive
“as required” treatment, such as the SleepWave
medical device, may prove to be an effective
solution.
Potential limitations of this study include the
absence of sleep data derived by
polysomnography; consequently, the findings
are entirely reliant on subjective assessment.
Also, the sub-sample population from which the
study cohort was obtained and the resulting
number of participants who provided complete
data sets for analysis, may have created bias. A
further limitation is the lack of a control group.
Conclusions
At study completion, all sleep parameters appeared
to have improved significantly. Considering the
ISI as a measure of treatment outcome, results
over time did not differ significantly between
participants with and without baseline data.
Of note, participants who were instructed
remotely did not demonstrate a reduction in
effectiveness of the SleepWave compared to those
with face-to-face instruction when comparing
pre and post ISI scores (p =.438). From this it
appears that the participants were well motivated
and the instruction via telephone and the DVD
training aid was fully adequate.
Adverse events
Two adverse events were reported to the study
investigators. One participant experienced a petit
mal seizure which did not occur while using the
device but during the following day. This
participant had a previous history of medical and
psychiatric conditions that could not be excluded
as the origin of the event.
The second adverse event reported was tinnitus-
like symptoms. On further investigation this
individual had concurrently undergone extensive
dental treatment at the same time as entering the
study. Therefore the cause of tinnitus could not
be unequivocally attributed to device use.
Neither of the reported adverse events in this
study are believed to be associated with the device,
but as the study provided no control group, no
comparison could be made. Both adverse events
are currently being evaluated to determine
conclusively that these events are not device-
related.
Discussion
This study provides new evidence supporting
vestibular nerve stimulation as a therapeutic
intervention for chronic insomnia, with significant
improvement in ISI mean scores and
classifications, sleep onset latency, total sleep time,
wake after sleep onset and sleep efficiency.
Sleep measures Baseline Day 30 Day 30 - Baseline p value
Recorded Sleep onset latency (mins) † 46.6 ± 28.5 (40.8) 28.3 ± 21.1 (22.5) -18.3 ± 22.1 (-17.7) <.001
Recorded total sleep time (mins) † 376.9 ± 63.3 (378.8) 415.6 ± 62.2 (413.6) 38.7 ± 67.1 (42 .0) =.001
Calculated total sleep time (mins) π 371.5 ± 72.8 (373.7) 418.0 ± 65.0 (420.9) 46.5 ± 69.4 (44.5) <.001
Recorded wake after sleep onset (mins) † 30.5 ± 21.9 (26.3) 13.2 ± 15.7 (9.3) -17.3 ± 23.2 (-13.1) <.001
Recorded sleep efciency† 0.8 ± 0.1 (0.8) 0.9 ± 0.1(0.9) 0.1 ± 0.1 (0.1) <.001
Calculated sleep efciency π 0.8 ± 0.1 (0.8) 0.9 ± 0.1(0.9) 0.1 ± 0.1 (0.1) <.001
# For the majority of the endpoints, distributions of the paired differences exhibited a depar ture from the
normality; therefore, change from baseline was assessed using the non-parametric Wilcoxon Signed Ranks test.
Participant documented times in sleep journal.
π Investigator calculations from time stamps recorded by participants in sleep journals.
Table 1. Mean ± Standard
Deviation (Median) summaries
for recorded and sleep measures
before and after intervention
with formal assessment for all
individuals with complete data
sets (n=43) #
H
A non-invasive “as
required” treatment, such
as the SleepWave, may
prove to be an effective
solution.
E
setting, control and long-term management of
symptoms is of great concern with a high
economic burden [26]. This type of therapy
could be valuable and well positioned in the
Primary Health Care sector, as it does not
appear to have the resource-intensive nature,
risks and side effects of existing insomnia
therapies L
suggest that using the SleepWave as a form of
therapy is effective in individuals with chronic
insomnia symptoms. However, the subjective
data on sleep and functioning needs to be
supplemented by objective measures.
As insomnia is one of the most common
presenting symptoms in the primary care
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MEDI CAMU NDI 54/2 2010 93
This type of therapy
could be valuable and
well positioned in the
Primary Health Care
sector.
E
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