The primary objective is to increase sleep quality, and to assess the effect of audio intervention (SmartSleep; Philips Respironics, Murrysville, PA) on deep sleep. Secondary objectives are to improve sleep efficiency, sleep duration, and to reduce…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Slaapproblematiek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are sleep quality as estimated by the Pittsburgh Sleep
Quality Index (PSQI) questionnaire, and the effect of audio intervention
(SmartSleep) on deep sleep.
Secondary outcome
Secondary outcomes are: sleep characteristics (total sleep time, REM, NREM,
Wake ups After Sleep Onset, sleep onset/latency) as measured with the
SmartSleep in monitoring modus. Stress, anxiety and depression are measured by
the DASS-42 questionnaire, whereas also the rate of increase in wake-up
cortisol levels will be monitored. Finally, tertiary outcomes are changes in
microbiota composition and gut functionality as studied in faecal samples
during the 1st and 2nd treatment periods.Daily a short questionnaire on
bedtime, wake-up and some life-style habits has to be filled in. A short
questionnaire on product tolerability will be offered together with the PSQI.
Background summary
A good night of sleep is well recognized as being beneficial for overall health
and well-being. Therefore, sleep disturbances being 20% in 12-65 y old persons
in The Netherlands are worrisome. A nutritional supplement could help in
improving sleep quality in healthy adults with sleep disturbances.
Study objective
The primary objective is to increase sleep quality, and to assess the effect of
audio intervention (SmartSleep; Philips Respironics, Murrysville, PA) on deep
sleep. Secondary objectives are to improve sleep efficiency, sleep duration,
and to reduce stress. The tertiary objective is to get insight in the possible
changes in the intestinal microbiota/microbiome
Study design
Double-blind randomized placebo-controlled cross-over trial
Intervention
In a cross-over, double-blind randomized controlled study, the subjects receive
an intervention and placebo product, each for 3 weeks. The two treatment
periods are separated by a washout periods of 2 weeks. Directly after the 2nd
treatment period a 3rd treatment period of 2 weeks will take place in which the
participants receive the same products as in treatment period 2 but
additionally will undergo an audio-sonic intervention using the SmartSleep
(Philips Respironics, Murrysville, PA). The intervention product (per serving)
consists of whey protein, tryptic casein hydrolysate, magnesium, zinc, vitamins
B6, niacin, vitamin D, and galacto-oligosaccharides (GOS). The placebo product
is skimmed milk powder. Products will be supplied as powders in a sachet, have
to be dissolved in luke warm water (100-150 ml) just before consumption, and
have to be consumed daily in the evening about 1 hour before going to bed.
Participants will be asked to collect the emptied and remaining sachets
Study burden and risks
For this study healthy volunteers are selected with sleep disturbances. When
the IP is effective, the participants will have a direct benefit during the
period the IP is consumed. Volunteers will be reimbursed for their time
investment which is estimated to be about 25 hours in total (including
information meeting, visits and phone calls). Subjects will visit the clinical
facilities 2 times, whereas questionnaires will be filled in on-line. There are
no known risks associated with the consumption of the IP or placebo, nor with
regard to the (non-invasive) data collection procedures. Subjects have to
perform the following study activities: * Collection of fecal spot sample at 2
time points * Collection of 5 saliva samples at 5 timepoints. * Intake of study
product during 8 weeks * Completing daily questionnaires during 8 weeks (on 9
timepoints PSQI and on 5 timepoints DASS-42) * Sleeping with SmartSleep device
during 35 days
Bronland 20
Wageningen 6708WH
NL
Bronland 20
Wageningen 6708WH
NL
Listed location countries
Age
Inclusion criteria
-Age 30-50 years -BMI 19.5 - 25 kg/m^2, as measured by the NIZO health and
lifestyle questionnaire -PSQI * 9 - willing and being able to consume a dairy
based product on a daily basis - Understand Dutch - Having access to the
internet and access to a mobile device for app download/function (phone or
tablet) - Apparently healthy according to the participant - Being available
during the study period (telephone and internet) - Willing to sign the written
informed consent - Accept use of all encoded data, including publication, and
the confidential use and storage of all encoded data.
Exclusion criteria
-Use of medicines to improve sleep (e.g. Benzodiazepines and benzodiazepine
ago-nists such as Temazepam, Zolpidem, Lormetazepam and Zopiclon, and
Barbiturates such as Fenobarbital) or supplements (protein, vitamins, herbs) in
general which im-prove sleep as assessed by the principal investigator. - Sleep
apnea or other diagnosed sleep diseases - Being allergic to dairy products or
any of the ingredients of the product - Being intolerant for prebiotics - Those
involved in shift working - Having a serious risk on a jetlag at the time of
starting or during the study period: re-turn (*1 week before a treatment
period) from an intercontinental flight and from a time-zone with >3 hours
difference. - Pregnant or breastfeeding women - Being treated by psychologist
for sleep or burnout - Diseases of the respiratory tract that cause serious
sleep issues, as assed by the medical arts - No use of soft and hard drugs
during the study period. - Having a history of medical or surgical events that
may significantly affect the intes-tine and/or digestion (e.g including:
Inflammatory bowel disease, hepatitis, pancreatitis, ulcers, gastrointestinal
or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy,
gastroenterostomy, or bowel resection; known or suspected gastrointes-tinal
disorders, colon or GI tract cancer - Mental status that is incompatible with
the proper conduct of the study (judgement is based on the personal view of the
researcher) - Alcohol consumption for men > 28 consumption units/week and
>4/day; for women: >21 units/week and >3/day - Reported weight loss or weight
gain of > 3 kg in the month prior to pre-study screen-ing, or intention to lose
weight during the study period - Reported slimming or medically prescribed diet
- Personnel of FrieslandCampina Research, NIZO and Philips Research, their
partners and their first and second degree relatives - Having a hearing
impairment (preventing hearing of tones of 80dB)'
- Peri- or postmenopausal women. Perimenopausal women will be defined based on
the criteria of hot flushed, irritability, irregular menstrual cycle and mood
swings (judgement is based on personal view of the subject themselves)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL70673.081.19 |
| Other | NL7919 |
| OMON | NL-OMON21623 |