Effect of melatonin on sleep in sulfur mustard exposed patients

Effect of melatonin administration on sleep quality in sulfur mustard exposed patients with sleep disorders

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015092924267N1

Enrollment

Registered

2015-11-23

Start date

2015-04-16

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorders. Disorders of initiating and maintaining sleep [insomnias]

Interventions

Intervention 1: Melatonin

N acetyl 5 methoxy tryptamine

3 mg

3 mg oral tablet

A pill every night for 8 weeks

Nature Made. Intervention 2: Placebo

3 mg oral tablet, A pill every night for 8 weeks

Tehran Chemistry Company.

Treatment - Drugs

Placebo

Melatonin

Nature Made

Eligibility

Sex/Gender

Male

Age

45 Years to 69 Years

Inclusion criteria

Inclusion criteria: • Inclusion criteria: Sulfur mustard-injured patients with mild [ Forced expiratory volume in 1 second (FEV1)=80% ] and moderate (50% = FEV1= 80%) lung damages which their sleep disorders were confirmed using polysomnography at sleep clinic of Baqiatallah University of Medical Sciences. • Exclusion criteria: Cigarette smoking or a history of exposure to any other respiratory pollutants; History of rhinitis allergique or other allergic diseases before exposure to sulfur mustard; History of asthma, lung cancer and pulmonary tuberculosis; Acute infection at upper and lower respiratory system; History of drugs consumption that is associated with pulmonary complications; History of systemic diseases or other chronic abnormalities which are associated with lung problems (such as heart disorders, kidney diseases, hepatitis, cirrhosis)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sleep Quality. Timepoint: before treatment, 8 weeks after treatment. Method of measurement: Pittsburgh Sleep Quality Index.;Daytime Sleepiness. Timepoint: before treatment, 8 weeks after treatment. Method of measurement: Epworth Sleepiness Scale.;The risk of Obstructive Sleep Apnea. Timepoint: before treatment, 8 weeks after treatment. Method of measurement: STOP Bang Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyedeh Soghra Mousavi

Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences

seyyedeh.s.mousavi@gmail.com+98 21 8248 2515

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 25, 2026