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Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients

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Capital Medical University

Status

Enrolling

Conditions

Chronic Insomnia

Treatments

Behavioral: sleep restriction and stimulus control
Behavioral: sleep hygiene education

Study type

Interventional

Funder types

Other

Identifiers

NCT06658184
SR-SC-insomnia

Details and patient eligibility

About

The study aims to validate the effect of sleep restriction and stimulus control on improving chronic insomnia patients' sleep habits and maladaptive sleep behaviors.

Full description

The purpose of sleep restriction is to reduce the patient's time in bed, bringing it closer to their actual sleep time, thereby improving sleep efficiency and quality. Stimulus control, on the other hand, aims to associate the bed with a rapid sense of falling asleep, reducing the negative association between the bed and insomnia.

Enrollment

88 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Meet the diagnostic criteria for insomnia disorder as per DSM-5.
  2. Pittsburgh Sleep Quality Index (PSQI) total score > 5.
  3. Age ≥ 18 years, at least a junior high school education level.
  4. Assessment of sleep-wake behavior by sleep diary.
  5. Assessment of "maladaptive sleep behavior" by self-designed 8-item questionnaire.
  6. Voluntary participation in the study and signing an informed consent form.

Exclusion criteria

  1. Presence of severe physical or severe mental illness, and suicide risk.
  2. Clinical diagnosis or suspicion of sleep-breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as individuals working in rotating shifts or with shift work.
  3. Pregnant or lactating women.
  4. Currently undergoing any form of psychological therapy.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

88 participants in 2 patient groups

sleep restriction and stimulus control
Experimental group
Treatment:
Behavioral: sleep restriction and stimulus control
Sleep hygiene education
Active Comparator group
Treatment:
Behavioral: sleep hygiene education

Trial contacts and locations

1

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Central trial contact

Hongxing Wang, MD & PhD

Data sourced from clinicaltrials.gov

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