Impact of Weighted Blankets on Sleep Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Thessaly
About this trial
Weighted blankets have been used to improve sleep quality in children with neurodevelopmental disorders. It is not known, however, whether weighted blankets can improve overnight sleep in healthy adults and those with poor sleep quality and what is the optimal weight of those blankets for achieving the best results.
AIMS: The purpose of the present study is to investigate the effect of 4 different weights of weighted blankets on sleep in participants with low sleep quality.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy individual
Disqualifiers
history of mental illness
history of epilepsy
any acute or chronic condition that would limit the ability of the patient to participate in the study
Trial design
Design model
Crossover
Treatments tested in this trial
Weighted Blanket
Other interventionParticipants will lie down and be covered with a weighted blanket.
Non Weighted Blanket
Other interventionParticipants will lie down and be covered with normal weight blanket (non-weighted blanket)
Treatment groups
20 Participants
are divided into 4 treatment groupsGroup A: ControlSham comparator 0 interventions
Group B: 7-Kg BlanketExperimental treatment 1 intervention
Group C: 9-Kg BlanketExperimental treatment 1 intervention
Group D: 14-Kg BlanketExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Efficiency
Sleep Efficiency is equal to total sleep time over Time spend in bed
Time frame
At baseline and at the end of the intervention (overnight sleep - 8 hours).Secondary outcomes
1
Total sleep time
Total Sleep Time is the total amount of sleep time scored during the total recording time
Time frame
At baseline and at the end of the intervention (overnight sleep - 8 hours).2
Insomnia Score
Score is derived from the Athens Insomnia Scale (AIS) questionnaire. The AIS consists of eight questions: questions 1-5 evaluate the quality of sleep at night, and questions 6-8 refer to vitality during the day. The score for each item ranges 0-3; 0 represents no problem; 1, a minor problem; 2, a marked problem; and 3, a very serious problem. The total score for the scale ranges 0-24.
Time frame
At baseline and at the end of the intervention (overnight sleep - 8 hours).Sponsors and contacts
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University of Thessaly
Lead sponsor
University of Nicosia
Collaborator
Source ClinicalTrials.gov