Effect of a Dietary Supplement on Quality of Life — SleepLift  

Quality of Life Clinical Trial

Official title: A Cross-over Pilot Trial to Determine the Effect of an LSU Patented Dietary Herbal Supplement on Quality of Life

Status Completed

Clinical Trial Summary

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, a finger oximeter and a sleep study will be done before and after each treatment week.

Clinical Trial Description

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 an actigraph and polysomnography. At the end of each treatment period subjects will have a chemistry panel, a CBC, Janus Kinase measured in the blood and a buffy coat will be archived. ;

Related Conditions & MeSH terms

• Quality of Life

• NCT number: NCT05323084
• Study type: Interventional
• Source: Pennington Biomedical Research Center
• Status: Completed
• Phase: N/A
• Start date: January 4, 2022
• Completion date: September 7, 2022