Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808-4124, United States
NCT Number: NCT05323084
The purpose of this research study is to evaluate the effect of a combination of 3 food components to improve the quality of life in people who have trouble sleeping. Ten subjects with insomnia will drink 2 ounces of the supplement or a placebo for 1 week and after a 2 weeks washout period, will take the treatment they did not take the first week. Questionnaires to evaluate quality of life, and a sleep study will be done before and after each treatment week.
Looking for future studies?
Notify Me50 year and older
All sexes
Interventional
Not applicable
Baton Rouge, Louisiana, 70808-4124, United States
Each participant will be in the study for about 1 month. The questionnaires consist of Chubon Quality of Life Rating, the Multi-dimensional Fatigue Inventory, Insomnia Severity Index, the Epworth Sleepiness, Pittsburgh Sleep Quality Index. Subjects will be screened with a medical questionnaire, vital signs, height, weight, oximetry to identify sleep apnea, a CBC and chemistry panel and the Insomnia severity Index. Weight, vital signs, adverse event questioning, dispensing and collection of test material will be done at each visit. During each treatment week subjects will wear an actigraph, keep a sleep diary and at the beginning and end of each treatment week subjects will have a polysomnography. At the end of each treatment period subjects will have a chemistry panel, a CBC, and a buffy coat will be archived.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 week of each intervention at bedtime with a 2-week washout period in between interventions
Other names: Placebo
Time frame: 1 week
Total score ranges from 20 to 140 with higher scores being better quality of life
Time frame: 1 week
Total Score ranges from 0 to 21 with higher sleep quality having lower numerical values
Time frame: 1 week
Total Score score 0-24 with higher scores having greater degree of sleepiness
Time frame: 1-week
Index of self-perceived general fatigue. Score range from 4 to 20 with high score indicative of more fatigue.
Time frame: 1 week
Index of self-perceived physical fatigue. Score range of 4 to 20 with higher score indicative more fatigue.
Time frame: 1 week
Index of self-perceived mental fatigue. Score ranges from 4 to 20 with higher scores indicative of more fatigue.
Time frame: 1-week
Determined by Polysomnography - time it takes for a person to fall asleep in min
Time frame: 1-week
Determined by polysomnography - total number of minutes a person is awake after having initially fallen asleep in min.
Time frame: 1-week
Determined by polysomnography - ratio of the total time spent asleep in a night compared to the total time spent in bed in percentage.
Pennington Biomedical Research Center
Other
A Cross-over Pilot Trial to Determine the Effect of an LSU Patented Dietary Herbal Supplement on Quality of Life
Acronym: SleepLift
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07742059
Anxiety, Anxiety Disorders
Antalya, Turkey (Türkiye)
View Trial DetailsNCT06750692
Brain Diseases, Cardiovascular Diseases
Afyonkarahisar, Turkey (Türkiye)
View Trial DetailsNCT07720752
Behavior, Climate Change Anxiety
Islamabad, Pakistan
View Trial DetailsNCT06654869
Cancer, Neoplasms
Erzurum, Yakutiye, Turkey (Türkiye)
View Trial Details