The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps (MISIT)
An Investigation Into the Effect of a Daily Magnesium and Melatonin Based Multi-Ingredient Dietary Supplement on Sleep Quality in Individuals With Self-Reported Nighttime Leg Cramps.
Participants are being invited to take part in a research study. Before deciding whether to take part, it is important for participants to understand why the research is being done and what it will involve.
Purpose: This study will investigate whether a multi-ingredient nutritional supplement containing magnesium and melatonin can improve sleep quality in adults who experience disrupted sleep due to nighttime leg cramps.
What participation involves: Participation lasts 8 weeks. Participants will be randomly assigned to take either the nutritional supplement or a placebo (inactive look-alike) every night before bed for 6 weeks. Participants will wear an Oura Ring wearable device on one finger continuously for 8 weeks throughout the study and complete short questionnaires using a smartphone app. The Oura Ring and study supplement will be sent to the participant's home address. Participants will never need to travel to a research centre; all contact with the research team will be by video call, phone, messaging, or email.
How long: Total involvement will be 8 weeks, made up of a 2-week baseline period and a 6-week supplementation period. Each day, participants will complete a short app-based questionnaire (approximately 1 minute). At the end of weeks 2, 4, 6, and 8, participants will complete additional app-based questionnaires (approximately 10 minutes).
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Tom Jameson, PhD
- 전화번호: +447794865520
- 이메일: tom.jameson@studysetgo.com
연구 연락처 백업
- 이름: Christopher Koscien, PhD
- 전화번호: +44 7847617414
- 이메일: chris.koscien@studysetgo.com
연구 장소
-
-
Florida
-
Palm Beach Gardens, Florida, 미국, 33418
- 모병
- StudySetGo Decentralised team
-
연락하다:
- Tom Jameson
- 전화번호: +44 7794865520
- 이메일: tom.jameson@studysetgo.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 40-75 years
- Self-reported poor sleep quality (PSQI >5) at screening
- Self-reported nocturnal leg cramp averaging ≥4 episodes per fortnight at screening
- Capacity to understand and provide electronic informed consent
- Willing to wear an Oura Ring wearable device continuously throughout the study period
- Access to a smartphone/tablet with iOS 15 or higher and Android 9 or higher and willing to install and use the Oura and Trialflare applications
- Be a resident of and permanently living in Florida with no planned travel across more than one time zone for at least 1 night during the study period
Exclusion Criteria:
- Current or recent (within 4 weeks of randomisation) use of melatonin, magnesium, or other supplements specifically taken for sleep or leg cramps or listed as an ingredient of the intervention supplement.
- Current use of any prescription medication
- Diagnosed sleep disorder (e.g. obstructive sleep apnoea, restless legs syndrome, insomnia disorder)
- Known or suspected secondary cause of nocturnal leg cramps (e.g. peripheral vascular disease, neurological condition, renal impairment, thyroid disorder)
- Any current or prior diagnosis of:
- Cancer or malignancy of any kind (prior malignancy is not exclusionary if the participant is in confirmed remission and has completed all treatment)
- Cardiovascular disease (e.g. hypertension, coronary artery disease, heart failure, arrhythmia, stroke, peripheral vascular disease)
- Autoimmune disorder (e.g. rheumatoid arthritis, lupus, multiple sclerosis)
- Gastrointestinal disorder (e.g. IBS, malabsorption syndromes)
- Neurological disorder (e.g. epilepsy, Parkinson's disease, dementia)
- Hepatic or renal impairment
- Diabetes mellitus (type 1 or type 2)
- Severe psychiatric disorder (e.g. schizophrenia, bipolar disorder)
- Myasthenia Gravis
- Known hypersensitivity or allergy to any ingredient in the active or placebo product
- Rotating shift work or irregular sleep patterns
- Current participation in another interventional clinical trial
- Inability to comply with study procedures or remote visit schedule
- Breastfeeding, pregnant, or planning to become pregnant during the study period
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: 위약
|
The placebo is manufactured by the same manufacturer that produces the active product (Vitaquest International, New Jersey, USA).
The placebo is visually similar to the active product and will be packaged in the same plain bottles as the active intervention to maintain the blind.
The placebo dose is up to 3 capsules per day taken with water.
Packaging is managed by Vitaquest International.
|
|
실험적: Magnesium and melatonin based multi-ingredient dietary supplement
|
The active intervention is a commercially available multi-ingredient dietary supplement, supplied by Imagine Biolabs LLC (trading as SaltWrap) and sold under the brand name Mag R&R.
The dose is up to 3 capsules per day taken 30 minutes before bedtime with water.
The product is stored at room temperature.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
기간: From enrollment to the end of treatment at 6 weeks
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire assessing sleep quality over the past month.
Scores range from 0 to 21, where higher scores indicate poorer sleep quality.
|
From enrollment to the end of treatment at 6 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
36-Item Short Form Health Survey (SF-36)
기간: From enrollment to the end of treatment at 6 weeks
|
The 36-Item Short Form Health Survey (SF-36) is a self-reported questionnaire assessing health-related quality of life across eight domains.
Scale scores range from 0 to 100, with higher scores indicating better health.
|
From enrollment to the end of treatment at 6 weeks
|
|
REM sleep assessed via Oura Ring wearable
기간: From enrollment to the end of treatment at 6 weeks
|
From enrollment to the end of treatment at 6 weeks
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .