Sleep TO Prevent Post-surgical Pain
A legfontosabb adatok
- Ki végzi
- Johns Hopkins University
- Hol
- Baltimore és Chestnut Hill (Egyesült Államok)Mind a 2 helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 252 fő, tervezett
- Kezdés
- 2025. jún. 13.
- Várható befejezés
- 2029. júl. 31.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Cognitive-Behavioral Therapy for Insomnia
- Bright Light therapy via the Re-Timer®
- Negative Ion exposure via IonMi Device
- Sleep / Knee Osteoarthritis Education
- A regiszteradat frissítve
- 2026. augusztus 7.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for people aged 60 or older with knee osteoarthritis who have trouble falling or staying asleep. They must be scheduled for a total replacement of one knee.
- Életkor
- 60 years and older
- Nem
- All sexes
- A betegség stádiuma
- Knee osteoarthritis, with a planned total replacement of one knee because of osteoarthritis. People must also have trouble falling or staying asleep.
- Korábbi kezelés
- People cannot join if they now take sleep medicines or have finished Cognitive Behavioral Therapy for Insomnia. They also cannot join if they used Bright Light or Negative Ion exposure in the past year. People must stop over-the-counter sleep aids (for example, melatonin) for at least 2 weeks before joining.
A részvétel fő kizáró okai
- Inflammatory rheumatic disease, seizure disorder, or taking disease-modifying antirheumatic drugs
- Serious mental health disorder, Bipolar I disorder, or substance or alcohol use disorder
- Serious sleep or body-clock disorder, or untreated sleep apnea
- Pregnant or breastfeeding
- Retina disease, past eye surgery (Lasik or cataract okay if more than 3 months ago), or taking medicines that make you sensitive to light
A regiszter feltételei, szó szerint
Mind a 16 feltétel megnézéseKevesebb
Ki vehet részt
- People with knee osteoarthritis,
- 60 years old and older,
- scheduled to have unilateral (one knee) total knee replacement surgery for osteoarthritis and
- have trouble falling or staying asleep
Ki nem vehet részt
- currently using medications to help sleep
- have completed Cognitive Behavioral Therapy for Insomnia
- taking photosensitizing medications
- are unwilling to discontinue over the counter sleep aids (for example, melatonin) for at least 2 weeks before enrolling
- have an inflammatory rheumatologic disorder, seizure disorder
- serious mental health disorder, Bipolar I disorder, substance or alcohol use disorder
- serious sleep or circadian rhythm disorder, untreated sleep apnea
- history of eye surgery (Lasik or cataract okay if more than 3 months ago)
- are taking disease-modifying antirheumatic drugs
- used either Bright Light or Negative Ion exposures in the past year
- are pregnant or lactating
- have retinal pathology
Helyszínek itt: Egyesült Államok
- Johns Hopkins School of MedicineBaltimore, Egyesült ÁllamokContact: Anna Kim-DahlRésztvevőt keres
- Mass General BrighamChestnut Hill, Egyesült ÁllamokContact: Anna Kim-DahlNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
This research study is being done to compare different methods of addressing sleep problems before total knee replacement surgery. These methods include Cognitive Behavioral Therapy and light exposure.
A vizsgálat 3 csoportja
- Cognitive Behavioral Therapy + Morning Bright Light exposureA vizsgált kezelés
Cognitive-Behavioral Therapy for Insomnia. This program will focus on changing the participant's sleep patterns, activities, and habits. Morning Bright Light involves wearing glasses (Re-Timer Device) that give off a special type of bright light for one full hour in the morning. The participant will be asked to wear these glasses every morning for about four weeks before surgery, four weeks after surgery and again for 1-week , 3-months after surgery. The participant will fill out a log to note light on/off times, any interruptions to light treatment, and primary activity while receiving the light exposure. The participant will also receive daily reminders to charge the device and turn it on during the scheduled time.
Kezelés: Cognitive-Behavioral Therapy for Insomnia és Bright Light therapy via the Re-Timer®
- Cognitive Behavioral Therapy for Insomnia + Negative Ion exposureMár használt kezelés, összehasonlításként
Cognitive-Behavioral Therapy for Insomnia. This program will focus on changing the participant's sleep patterns, activities, and habits. Negative Ion exposure. This procedure involves wearing a light weight negative ionizer (IonMi Device) around the neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. the participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery The participant will also receive daily reminders to charge the device and turn it on during the scheduled time.
Kezelés: Cognitive-Behavioral Therapy for Insomnia és Negative Ion exposure via IonMi Device
- Sleep / Knee Osteoarthritis Education + Negative Ion exposureMár használt kezelés, összehasonlításként
Sleep / Knee Osteoarthritis Education. This program will focus on increasing the participant's knowledge about sleep, sleep disorders and knee osteoarthritis. Negative Ion exposure. This procedure involves wearing a light weight negative ionizer (IonMi Device) around the neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. The participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery The participant will also receive daily reminders to charge the device and turn it on during the scheduled time.
Kezelés: Negative Ion exposure via IonMi Device és Sleep / Knee Osteoarthritis Education
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- A regiszteradat frissítve
- 2026. augusztus 7.