Evaluation of Sleep in Insomnia Based on the Use of the Device "Smart Topper" used during Sleeping

Evaluation of Sleep by the Use of Sleep Device Smart Topper in Insomnia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005301

Enrollment

Registered

2020-08-10

Start date

2020-08-10

Completion date

Unknown

Last updated

2020-08-18

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

Conditions

None listed

Interventions

Medical Device : Name of medical device: Smart Topper Application: Sleeping devices that use low-frequency electromagnetic signals to improve sleep quality by engaging in restoring the balance of the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Over 19 Years Old 2. Patients with primary insomnia (based on DSM-V) 3. Non-shift workers 4. A person who has no history of drug or alcohol dependence.

Exclusion criteria

Exclusion criteria: 1. Persons with other sleep disorders other than insomnia; 2. Suspected of severe sleep apnea (STOPBAG>14) 3. Persons with severe anxiety or depression (BAI>31, BDI>28) 4. Those who have been treated with sleeping pills within 14 days prior to the base date; 5. Person with other major internal diseases 6. A person who is not qualified for this test as determined by the Research Director. 7. Patients with such low education or intellectual disabilities that it is difficult to evaluate a questionnaire

Design outcomes

Primary

Measure	Time frame
Polysomnography (PSG), Pittsburg sleep quality index (PSQI)	—

Secondary

Measure	Time frame
Insomnia severity index (ISI), Epworth sleepiness scale (ESS), Beck depression inventory (BDI), Stanford sleep scale (SSS)	—

Countries

Korea, Republic of

Contacts

Public ContactYong Won Cho

Keimyung University Dongsan Medical Center

Outcome results