Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia (LavenAromDM)

Efficacy and Safety of Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia

This study is designed as cross-over double-blind placebo-controlled randomized clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the study and randomly assign to first intervention and first placebo groups.The primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the end of the study.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Sleep Disturbance
• Intervention / Treatment: Drug: Lavender Oil; Drug: Placebos

Detailed Description

Considering the high prevalence of sleep disturbance in diabetic patients and the effectiveness of lavender in treatment of sleep disorders in this study the efficacy of Lavender aromatherapy in sleep disorder and metabolic parameters in diabetic patients will be investigated. This study is designed as cross-over double-blind placebo-controlled randomized clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the study and randomly assign to first intervention and first placebo groups.The primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the end of the study.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • Shiraz University of Medical Sciences
    • Shiraz, Fars, Iran, Islamic Republic of
      • Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diabetes mellitus type 2
• Age between 25-65 years old
• Fasting Blood Sugar between 70-130
• 2 hour post prandial glucose less than 180.
• HbA1C less than 7
• Sleep disorder according to pittsburgh Insomnia Rating Scale more than 5.

Exclusion Criteria:

• Any systemic illnesses
• Use of sedative or antidepressant drugs
• Pregnancy
• Lactation
• History of allergic reaction to Lavender
• History of allergic rhinitis, asthma and respiratory disorders
• Anosmia
• Headache that start with smell
• Cigarette smocking or substance abuse
• Hospitalization or surgery within 1 months ago.
• Work shift

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lavender oil	Drug: Lavender Oil; The intervention group pour 3 drops of Lavender essential oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks
Placebo Comparator: vehicle (Almond oil)	Drug: Placebos; The placebo group pour 3 drops of Almond oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Insomnia Rating Scale	evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Blood Sugar	blood sample	4 week
2 hours Post Prandial Glucose	blood sample	4 week
Serum Insulin	blood sample	4 week
C Reactive Protein	blood sample	4 week
Uric acid	blood sample	4 week
Creatinine	blood sample	4 week
Triglyceride	blood sample	4 week
Cholesterol	blood sample	4 week
Low Density Lipoprotein	blood sample	4 week
High Density Lipoprotein	blood sample	4 week
Aspartate Aminotransferase	blood sample	4 week
Alanine Aminotransferase	blood sample	4 week
weight	Scale	4 week
Body Mass Index	Body Mass Index	4 week
waist circumference	Meter	4 week
hip circumference	Meter	4 week
Systolic Blood Pressure	Blood Pressure measurement by digital sphygmometer	4 week
Diastolic Blood Pressure	Blood Pressure measurement by digital sphygmometer	4 week

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Investigators: Study Chair: Mesbah Shams, M.D., Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Sleep Wake Disorders; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyssomnias; Parasomnias
• Other Study ID Numbers: 95010112052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No