Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05294133 |
| Other study ID # |
2021-A00862-39 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
March 2022 |
| Source |
Universite du Littoral Cote d'Opale |
| Contact |
Pauline BARON, Phd Student |
| Phone |
0673681126 |
| Email |
pauline_baron[@]orange.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
One third of men and women are not satisfied with their sleep. A non-drug countermeasure to
improve sleep in insomniacs could be adapted physical activity (APA). However, research is
needed because the literature is limited and the few studies are most often based on
subjective data with a great methodological disparity. Within the framework of the care
pathway of Dr ARON's patients, sleep doctor at the Sommeil Morphée Center of the Grande
Synthe Polyclinic (59), the objective of this project is to make an APA program more reliable
in order to improve sleep, to understand the underlying mechanisms and to include APA in the
therapeutic management.
Description:
According to the 2019 National Sleep and Vigilance Institute survey, in France, one-third of
men and women are not satisfied with their sleep, and nearly half struggle to fall asleep or
return to sleep. Given the growing evidence of the harmful effects of lack of sleep, its
alteration on health, these figures are alarming.
Insomnia is characterized by dissatisfaction with the quantity or quality of sleep,
difficulty initiating and/or maintaining sleep, and early morning awakenings at least three
times a week for a minimum period of three months.
In a Sleep Medicine Reviews report, it was shown that many patients diagnosed with insomnia
had a physiological hyperarousal disorder that resulted in poor sleep, which has been found
in insomniacs in numerous studies. It is observed in particular on the autonomic nervous
system by a low variability of heart rate and a high level of noradrenaline reflecting a
dominant sympathetic axis. An anxiogenic and depressive profile and elevated cortisol levels
are also often associated with this hyperarousal encountered in insomniacs. In addition, an
alteration of the circadian rhythm seems to favor insomnia. Indeed, a decrease in core
temperature and cortisol levels in the evening are primary mechanisms for sleep onset. A
study showed an elevated sleep latency in individuals with this delayed circadian temperature
rhythm. In the same study, a high wake-up time after sleep was associated with a high core
temperature. Regarding cortisol, a smaller decline in cortisol and higher cortisol levels at
the end of the day are associated with shorter sleep duration, lower sleep efficiency, and
poor subjective sleep quality.
Although a first treatment of insomnia would be to find a good lifestyle and optimal sleep
conditions, the majority of first-line remedies in the treatment of insomnia remain
pharmacological today, through the short- or medium-term prescription of hypnotics,
neuroleptics, anxiolytic benzodiazepines or some antidepressants.
If the practice of regular physical activity is now well known to improve overall health,
what about sleep?
In 2017, the investigators published a study showing that an adapted Physical Activity (PA)
program improved sleep in a population of young women. Overall, studies regarding the effects
of exercise and physical activity are still recent but increasingly confirm the beneficial
effects of PA on sleep.
Indeed, the literature reveals that there is an inverse correlation between the amount of PA
and the severity of sleep disturbance.
In fact, it appears that regular physical activity decreases the recurrence of insomnia. In
adults over 40 years of age with sleep disorders, a 10- to 16-week training program very
significantly improved the qualitý of sleep and shortened sleep latency.
According to these same authors, PA thus poses as a reliable alternative to pharmacological
management by showing a positive effect of PA on sleep.
However, further work is needed because the literature remains limited and sometimes
contradictory. Moreover, the studies are most often based on subjective data with a great
methodological disparity. The type of physical activity proposed in these different studies
is very variable, ranging from aerobic exercise to muscle strengthening to yoga or other
relaxation activities. To the best of our knowledge, there is no consensus on the intensity
of exercise to be preferred to improve sleep.
1.1 Objectives
The objective of this project is therefore to evaluate the effects of an APA program in
insomnia treatment therapies.
The follow-up of physiological and medical markers, throughout the APA program, will make it
possible to observe the effect of the DK pulse intervention, to determine the mechanisms
underlying the improvement of sleep by physical activity and thus to propose an optimization
of the programs dedicated to the improvement of sleep.
The aim will be to extend this program from the local basin to the regional level (or even
beyond) and to use the network of local APA structures to make this management as easy as
possible for the patients.
1.1 General assumptions
The investigators hypothesize that the 12-week physical activity program will improve
objective and subjective sleep in patients with insomnia. This improvement in sleep will be
explained in part by a decrease in capillary cortisol levels, an increase in heart rate
variability, a decrease in stress and/or an increase in circadian rhythm amplitude throughout
the PA program.
This study is the second of three studies of the thesis of Pauline Baron (ULCO PhD student,
financed by the Haut de France Region, in collaboration with health care services (Dr Aron).
The treating physicians of patients suffering from insomnia direct their patients to the
dedicated sleep consultations for clinical assessment.
The sleep specialists propose physical activity within the framework of a prescription, after
diagnostic and etiological assessments, and evaluation of the patients' symptoms, the
comorbidities are evaluated in the same way as the motivation of the participants, and they
ask the patients grouping the various criteria of inclusion/exclusion of the study if they
wish to participate in a scientific study.
After the patient's informed consent, they are referred to Pauline BARON.
During the inclusion visit, the investigator reminds them in detail of the objectives and the
course of the protocol. An information leaflet is given to each participant, who signs an
authorization to participate in the study, accepting in particular the randomization of the
groups (AP or control). The control group will not receive any intervention.
Adapted Physical Activities are programmed within the DK Pulse association, one of the 138
structures labelled Maison du Sport Santé
(https://www.sports.gouv.fr/accueil-du-site/actualites/article/les-premieres-maisons-sport-sa
nte-sont-desormais-connues ). The physical activity program is a 12-week program with 1 hour
of aerobic type physical activity, of moderate intensity, 3 times a week (duration, frequency
and intensity presumed to date according to the state of the art). The intensity of the
physical activity (between 60 and 80% of VO2max) will be controlled by an RPE scale and a
heart rate monitor.
The physical activity of the patients will be financially supported by the university.
As part of the care pathway, the investigators will evaluate different variables.
The variables will be measured at T0, T6 and T12 weeks for the 2 groups.
The following anthropometric and physiological parameters are measured:
Height (Tanita Leicester HR001 electronic height gauge); Body mass and composition (Tanita
DC-360) Resting blood pressure (non-dominant arm, sitting position, Omron M3); White blood
cell count measurement by capillary measurement (HemoCue® WBC DIFF Analyzer). Lack of sleep
negatively affects the immune system. It is therefore interesting, especially in this health
context, to measure the white blood cell count in patients suffering from insomnia, in order
to prevent a possible infection.
Hair sampling for cortisol measurement (only at T0 and T12). The measurement of hair cortisol
is essential in the care of a patient suffering from insomnia. It reflects the activity of
the hypothalamic-pituitary-adrenal axis (HPA). An abnormally high level of cortisol and a
disturbance of this axis can be a triggering or aggravating factor of insomnia.
Cardiorespiratory capacity on an ergometer (Monark e939): YMCA incremental submaximal test,
up to 85% of the theoretical HR max, allowing to evaluate by projection the Maximum Aerobic
Power (MAP) and the associated maximal O2 consumption (VO2max).
The evaluation is completed by taking an "e-celsius bodycap" capsule. This capsule allows
continuous monitoring of the patient's core temperature. It is naturally eliminated in the
stool. The follow-up of the central temperature is essential in the course of care of an
insomniac patient. Indeed, it is one of the reflections of the biological clock and therefore
allows us to observe the circadian rhythm and its amplitude.
At the end of this visit, patients will leave with :
an accelerometer, a Dreem research 2 headband a sleep diary and a physical activity log, a
heart rate monitor (Polar H10).
During the following week, the participants equipped with the accelerometer on their wrist
(non-dominant arm), fill out a daily sleep diary: wake-up and bedtime, naps.
They sleep with an EEG headband (Dreem 2 Research) that provides data for estimating the
different stages of sleep.
The accelerometer allows to measure some sleep parameters such as total sleep time and time
of nocturnal awakenings, the amount of physical activity and the associated energy
expenditure (Actilife 6 software) during the 7 days. A PA diary will also be completed daily
(type, intensity, duration).
Participants will wear the heart rate belt for 3 nights (from bedtime to sunrise) to record
RR intervals (precise duration between each heartbeat) from which heart rate variability will
be extracted (over a minimum interval of 5 hours). The frequency analysis of the RR signal
allows to evaluate the respective activations of the sympathetic and parasympathetic nervous
systems.
Each device is pre-programmed, no additional manipulation is necessary.
At the end of the 7 days, the participants return the equipment and answer several
questionnaires:
On sleep and sleepiness: Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI)
and EPWORTH sleepiness scale On stress and quality of life: Perceived Stress Scale (PSS) and
the Short Form Health Study (SF 36) On PA level: International Fitness Scale (IFIS)
