Diabetes Mellitus, Type 2, Sleep Disturbance
Conditions
Brief summary
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.
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.
Interventions
DRUGLavender 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
DRUGPlacebos
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
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Lavender Essential oil as medication and almond oil as placebo put in similar dark buttle and the head of placebo bottle aromatized whit Lavender Essential oil and all of participants, care provider, investigator and outcomes assessor will be blind.
Intervention model description
40 diabetic patients with sleep disorder with the inclusion criteria will enter into the crossover study and randomly assign to treatment or placebo groups.
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Insomnia Rating Scale | 4 weeks | evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2 hours Post Prandial Glucose | 4 week | blood sample |
| Serum Insulin | 4 week | blood sample |
| C Reactive Protein | 4 week | blood sample |
| Uric acid | 4 week | blood sample |
| Creatinine | 4 week | blood sample |
| Triglyceride | 4 week | blood sample |
| Cholesterol | 4 week | blood sample |
| Low Density Lipoprotein | 4 week | blood sample |
| Fasting Blood Sugar | 4 week | blood sample |
| Aspartate Aminotransferase | 4 week | blood sample |
| Alanine Aminotransferase | 4 week | blood sample |
| weight | 4 week | Scale |
| Body Mass Index | 4 week | Body Mass Index |
| waist circumference | 4 week | Meter |
| hip circumference | 4 week | Meter |
| Systolic Blood Pressure | 4 week | Blood Pressure measurement by digital sphygmometer |
| Diastolic Blood Pressure | 4 week | Blood Pressure measurement by digital sphygmometer |
| High Density Lipoprotein | 4 week | blood sample |
Countries
Iran
Outcome results
None listed